136
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City, Philippines Trunk Line +63 2 857 1900 Fax +63 2 807 0751 Website: www.fda.gov.ph Email: [email protected] 1 Provisional List of Comparator Products for in vivo and/or in vitro Equivalence Studies (as of 11 July 2019) Active Ingredient Dosage Strength and Form Comparator Drug 1 Marketing Authorization Holder [Manufacturer] Registration Number Abacavir (as sulfate) 300mg Tablet ZIAGEN ViiV Healthcare UK Ltd. 2 Not available locally ViiV Healthcare Co. 3 Abacavir (as sulfate) + Lamivudine 600mg/300mg Tablet KIVEXA ViiV Healthcare UK Ltd. 2 Not available locally EPZICOM ViiV Healthcare Co. 3 Abacavir (as sulfate) + Lamivudine + Zidovudine 300mg/150mg/30 0mg Tablet TRIZIVIR ViiV Healthcare UK Ltd. 2 Not available locally ViiV Healthcare Co. 3 Abacavir (as sulfate) + Dolutegravir (as sodium) + Lamivudine 600mg/50mg/300 mg Tablet TRIUMEQ ViiV Healthcare UK Ltd. 2 Not available locally ViiV Healthcare Co. 3 Abiraterone Acetate 250mg Tablet ZYTIGA Johnson & Johnson (Phils.), Inc. [Patheon Inc. Canada] DR-XY41696 500mg Tablet ZYTIGA Janssen-Cilag Ltd. 2 Not available locally Janssen Biotech Inc. 3 Acarbose 25mg Tablet PRECOSE Bayer Healthcare Pharmaceuticals Inc. 3 Not available locally 50mg Tablet GLUCOBAY Bayer Philippines, Inc. [Bayer Pharma AG Germany] DRP-3657 100mg Tablet GLUCOBAY Bayer Philippines, Inc. [Bayer Pharma AG Germany] DRP-3658 Aceclofenac 100 mg Film- Coated Tablet PRESERVEX Almirall Limited UK 2 Not available locally Acetazolamide 250 mg Tablet DIAMOX Wyeth Phils., Inc. [Wyeth Lederle Ltd. India] DR-2928 Acetylcysteine Capsule Available orally administered dosage forms of the comparator product/reference drug (FLUIMUCIL of The Cathay Drug Co., Inc. manufactured by Zambon Switzerland Ltd.) are in effervescent tablet and powder or granules for oral solution. In this regard, provide in vivo or in vitro equivalence evidence, whichever is applicable, using a comparator in the same dosage form purchased from a country participating in the International Powder or Granules for Oral Suspension

 · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

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Page 1:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

Republic of the Philippines

Department of Health

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City, Philippines Trunk Line +63 2 857 1900 Fax +63 2 807 0751 Website: www.fda.gov.ph Email: [email protected]

1

Provisional List of Comparator Products for in vivo and/or in vitro Equivalence Studies

(as of 11 July 2019)

Active Ingredient Dosage Strength

and Form

Comparator

Drug1

Marketing

Authorization Holder

[Manufacturer]

Registration

Number

Abacavir (as sulfate) 300mg Tablet ZIAGEN ViiV Healthcare UK Ltd.2 Not available

locally ViiV Healthcare Co.3

Abacavir (as sulfate)

+ Lamivudine

600mg/300mg

Tablet

KIVEXA ViiV Healthcare UK Ltd.2 Not available

locally EPZICOM ViiV Healthcare Co.3

Abacavir (as sulfate)

+ Lamivudine +

Zidovudine

300mg/150mg/30

0mg Tablet

TRIZIVIR ViiV Healthcare UK Ltd.2 Not available

locally ViiV Healthcare Co.3

Abacavir (as sulfate)

+ Dolutegravir (as

sodium) +

Lamivudine

600mg/50mg/300

mg Tablet

TRIUMEQ ViiV Healthcare UK Ltd.2 Not available

locally ViiV Healthcare Co.3

Abiraterone Acetate 250mg Tablet ZYTIGA Johnson & Johnson

(Phils.), Inc. [Patheon Inc.

– Canada]

DR-XY41696

500mg Tablet ZYTIGA Janssen-Cilag Ltd.2 Not available

locally Janssen Biotech Inc.3

Acarbose 25mg Tablet PRECOSE Bayer Healthcare

Pharmaceuticals Inc.3

Not available

locally

50mg Tablet GLUCOBAY Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DRP-3657

100mg Tablet GLUCOBAY Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DRP-3658

Aceclofenac 100 mg Film-

Coated Tablet

PRESERVEX Almirall Limited – UK2 Not available

locally

Acetazolamide 250 mg Tablet DIAMOX Wyeth Phils., Inc. [Wyeth

Lederle Ltd. – India]

DR-2928

Acetylcysteine Capsule Available orally administered dosage forms of the comparator

product/reference drug (FLUIMUCIL of The Cathay Drug Co.,

Inc. manufactured by Zambon Switzerland Ltd.) are in

effervescent tablet and powder or granules for oral solution. In

this regard, provide in vivo or in vitro equivalence evidence,

whichever is applicable, using a comparator in the same dosage

form purchased from a country participating in the International

Powder or

Granules for Oral

Suspension

Page 2:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

2

Council for Harmonization (ICH). Documentary proof of

purchase should be provided.

Acetylsalicylic Acid

(Aspirin)

30 mg Tablet COR-30 Pascual Labs., Inc.

[Pascual Labs., Inc.]

DR-XY17534

80 mg Tablet ASPILETS LR Imperial, Inc. [Amherst

Labs., Inc.]

DR-2350

100 mg Tablet BAYER

ASPIRIN

Bayer Phils., Inc. [Bayer

Bitterfeld GmbH –

Germany]

DRGDA

00000002

300 mg Tablet BAYER

ASPIRIN

Bayer Phils., Inc. [Bayer

Bitterfeld GmbH –

Germany]

DR-XY35870

325 mg Tablet Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-5053

100 mg Enteric-

coated Tablet

BAYPRIN EC Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY23747

Aciclovir 200 mg Tablet ZOVIRAX GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome S.A.

– Spain]

DR-XY2013

400 mg Tablet ZOVIRAX GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome S.A.

– Spain]

DR-XY8177

800 mg Tablet ZOVIRAX GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome S.A.

– Spain]

DR-XY19137

200 mg/5 mL Oral

Suspension

ZOVIRAX GlaxoSmithKline UK2 Not available

locally Mylan Pharmaceuticals,

Inc.3

Acitretin 10mg Capsule NEOTIGASON Pascual Pharma

Corporation [Patheon Inc.

– Canada]

DR-XY13978

17.5mg Capsule SORIATANE Stiefel Laboratories Inc.3 Not available

locally

22.5mg Capsule SORIATANE Stiefel Laboratories Inc.3 Not available

locally

25mg Capsule NEOTIGASON Actavis UK Ltd.2 Not available

locally SORIATANE Stiefel Laboratories Inc.3

Adefovir Dipivoxil 10mg Tablet HEPSERA GlaxoSmithKline

Philippines Inc.

[GlaxoSmithKline

(Tianjin) Co. Ltd. – China]

DR-XY29597

Afatinib (as

Dimaleate)

20mg Tablet GIOTRIF Boehringer Ingelheim

(Phil.) Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY43779

30mg Tablet GIOTRIF Boehringer Ingelheim

(Phil.) Inc. [Boehringer

DR-XY43780

Page 3:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

3

Ingelheim Pharma GmbH

& Co. KG – Germany]

40mg Tablet GIOTRIF Boehringer Ingelheim

(Phil.) Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY43782

50mg Tablet GIOTRIF Boehringer Ingelheim

(Phil.) Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY43781

Agomelatine 25 mg Film-

Coated Tablet

VALDOXAN Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY41362

Albendazole 400 mg Chewable

Tablet

ZENTEL GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

(Phils.)]

DR-XY13050

200 mg/5 mL Oral

Suspension

ZENTEL

GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

(Phils.)]

DR-XY21457

Alendronic Acid (as

Alendronate sodium)

70 mg Tablet FOSAMAX Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme (Italia) S.p.A. –

Italy]

DR-XY27118

Alendronic Acid (as

Alendronate sodium)

+ Cholecalciferol

(Vitamin D3)

70 mg/2,800 IU

Tablet

FOSAVANCE Merck Sharp & Dohme

(I.A.) Corp. [Frosst Iberica

S.A. – Spain]

DR-XY31364

70 mg/5,600 IU

Tablet

FOSAVANCE Merck Sharp & Dohme

(I.A.) Corp. [Frosst Iberica

S.A. – Spain]

DRP-5860

(DR-XY35366)

Alfuzosin

hydrochloride

2.5 mg Tablet XATRAL Sanofi-Aventis Phils., Inc.

[Sanofi-Winthrop Industrie

S.A. – France]

DRP-191

5 mg Sustained-

release Tablet

XATRAL SR Sanofi-Aventis Phils., Inc.

[Sanofi-Winthrop Industrie

S.A. – France]

DR-XY23216

10 mg Sustained-

release Tablet

XATRAL OD Sanofi-Aventis Phils., Inc.

[Sanofi-Winthrop Industrie

S.A. – France]

DRP-072

Aliskiren (as

hemifumarate)

150mg Tablet RASILEZ Novartis Healthcare Phils.,

Inc. [Novartis Farma

S.p.A. – Italy]

DR-XY33881

300mg Tablet RASILEZ Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Italy]

DR-XY33880

Aliskiren (as

hemifumarate) +

150mg/5mg

Tablet

RASILAMLO Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Stein AG – Switzerland]

DR-XY42035

Page 4:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

4

Amlodipine (as

besilate)

300mg/5mg

Tablet

RASILAMLO Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Stein AG – Switzerland]

DR-XY42034

Aliskiren (as

hemifumarate) +

Hydrochlorothiazide

150mg/12.5mg

Tablet

RASILEZ HCT Novartis Not available

locally TEKTURNA

HCT

Noden Pharma DAC3

150mg/25mg

Tablet

RASILEZ HCT Novartis Not available

locally TEKTURNA

HCT

Noden Pharma DAC3

300mg/12.5mg

Tablet

RASILEZ HCT Novartis Not available

locally TEKTURNA

HCT

Noden Pharma DAC3

300mg/25mg

Tablet

RASILEZ HCT Novartis Not available

locally TEKTURNA

HCT

Noden Pharma DAC3

Allopurinol 100 mg Tablet ZYLOPRIM Aspen Phils., Inc. [Aspen

Bad Oldesloe GmbH –

Germany]

DR-273

300 mg Tablet ZYLOPRIM Aspen Phils., Inc. [Aspen

Bad Oldesloe GmbH –

Germany]

DR-10173

Alogliptin (as

benzoate)

6.25 mg Tablet VIPIDIA Takeda UK Ltd.2 Not available

locally NESINA Takeda Pharmaceuticals

USA Inc.3

12.5 mg Tablet VIPIDIA Takeda UK Ltd.2 Not available

locally NESINA Takeda Pharmaceuticals

USA Inc.3

25 mg Tablet VIPIDIA Takeda UK Ltd.2 Not available

locally NESINA Takeda Pharmaceuticals

USA Inc.3

Alogliptin (as

benzoate) +

Metformin

hydrochloride

12.5 mg/500 mg

Tablet

VIPDOMET Takeda UK Ltd.2 Not available

locally KAZANO Takeda Pharmaceuticals

USA Inc.3

12.5 mg/1g Tablet VIPDOMET Takeda UK Ltd.2 Not available

locally KAZANO Takeda Pharmaceuticals

USA Inc.3

Alogliptin (as

benzoate) +

Pioglitazone

hydrochloride

12.5 mg/15 mg

Tablet

OSENI Takeda Healthcare Phils.,

Inc. [Takeda Pharm’l Co.,

Ltd. Osaka Plant – Japan]

DR-XY45782

12.5 mg/30 mg

Tablet

OSENI Takeda Healthcare Phils.,

Inc. [Takeda Pharm’l Co.,

Ltd. Osaka Plant – Japan]

DR-XY45783

12.5 mg/45 mg

Tablet

OSENI Takeda Pharmaceuticals

USA Inc.3

Not available

locally

25 mg/15 mg

Tablet

OSENI Takeda Healthcare Phils.,

Inc. [Takeda Pharm’l Co.,

Ltd. Osaka Plant – Japan]

DR-XY45784

Page 5:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

5

25 mg/30 mg

Tablet

OSENI Takeda Healthcare Phils.,

Inc. [Takeda Pharm’l Co.,

Ltd. Osaka Plant – Japan]

DR-XY45785

25 mg/45 mg

Tablet

OSENI Takeda Pharmaceuticals

USA Inc.3

Not available

locally

Alprazolam 250mcg Tablet XANOR Pfizer Inc. [Sanico NV –

Belgium]

DRP-2146

500mcg Tablet XANOR Pfizer Inc. [Pfizer

Pharmaceutical LLC –

Puerto Rico]

DR-XY14607

1mg Tablet XANOR Pfizer Inc. [Pfizer

Pharmaceutical LLC –

Puerto Rico]

DR-XY16774

2mg Tablet XANAX Pharmacia and Upjohn

Co.3

Not available

locally

500mcg

Controlled-

Release Tablet

XANOR XR Pfizer Inc. [Sanico NV –

Belgium]

DRP-2048

1mg Controlled-

/Extended-Release

Tablet

XANAX XR Pharmacia and Upjohn3 Not available

locally

2mg Controlled-

Release Tablet

XANAX XR Pharmacia and Upjohn3 Not available

locally

3mg Controlled-

Release Tablet

XANAX XR Pharmacia and Upjohn3 Not available

locally

Alverine Citrate

60mg Capsule SPASMONAL Meda Pharmaceuticals2 Not available

locally

120mg Capsule SPASMONAL

FORTE

Meda Pharmaceuticals2 Not available

locally

Ambrisentan 5mg Tablet VOLIBRIS GlaxoSmithKline

Philippines, Inc. [Patheon

Inc. – Canada]

DR-XY39400

10mg Tablet VOLIBRIS GlaxoSmithKline UK2 Not available

locally Gilead Sciences Inc.3

Ambroxol

hydrochloride

15 mg Lozenge STREPSILS

CHESTY

COUGH

Zuellig Pharma Corp.

[Reckitt Benckiser

Healthcare Manufacturing

(Thailand) Ltd. – Thailand]

DR-XY34819

STREPSILS

CHESTY

COUGH

Zuellig Pharma Corp.

[Reckitt Benckiser

Healthcare Manufacturing

(Thailand) Ltd. – Thailand]

DR-XY42567

20 mg Lozenge MUCOANGIN Boehringer Ingelheim

(Phil.), Inc. [Delpharm

Reims S.A.S. – France]

DR-XY33181

Page 6:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

6

30 mg Tablet MUCOSOLVAN Boehringer Ingelheim

(Phil.), Inc. [Interphil

Labs., Inc.]

DR-XY145

MUCOSOLVAN Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY41618

ZOBRIXOL Natrapharm, Inc. [Hizon

Labs., Inc.]

DR-XY5348

MYRACOF Medichem Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY15803

AMBROLEX GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham]

DRP-4352

(DR-XY21034)

75 mg Sustained-

Release (Retard)

Capsule

MUCOSOLVAN Boehringer Ingelheim

(Phil.), Inc. [PT.

Boehringer Ingelheim

Indonesia – Indonesia]

DR-XY18553

MUCOSOLVAN Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY41726

AMBROLEX

OD

GlaxoSmithKline Phils.,

Inc. [China Resources

Zizhu Pharm’l Co., Ltd. –

China]

DR-XY25555

Amiodarone

hydrochloride

100mg Tablet CORDARONE Sanofi-Aventis/Zentiva2 Not available

locally

200 mg Tablet CORDARONE Sanofi-Aventis Phils., Inc.

[Sanofi-Winthrop Industrie

S.A. – France]

DRP-043

Amisulpride 50mg Tablet SOLIAN Sanofi-Aventis – UK2 Not available

locally

100mg Tablet SOLIAN Sanofi-Aventis – UK2 Not available

locally

200mg Tablet SOLIAN Sanofi-Aventis Philippines,

Inc. [Sanofi Winthrop

Industrie – France]

DR-XY25188

400mg Tablet SOLIAN Sanofi-Aventis Philippines,

Inc. [Sanofi Winthrop

Industrie – France]

DR-XY28329

Amlodipine (as

besilate)

2.5mg Tablet NORVASC Pfizer Inc.3 Not available

locally

5 mg Tablet NORVASC Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-3419

(DR-XY15374)

Page 7:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

7

10 mg Tablet NORVASC Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-3429

(DR-XY16948)

Amlodipine (as

besilate) +

Atorvastatin (as

calcium)

2.5mg/10mg

Tablet

CADUET Pfizer Inc.3 Not available

locally

2.5mg/20mg

Tablet

CADUET Pfizer Inc.3 Not available

locally

2.5mg/40mg

Tablet

CADUET Pfizer Inc.3 Not available

locally

5 mg/10 mg

Tablet

ENVACAR /

NORVASC

PROTECT

Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-2791

(DR-XY30120)

5 mg/20 mg

Tablet

ENVACAR /

NORVASC

PROTECT

Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY30121

5mg/40mg Tablet CADUET Pfizer Inc.3 Not available

locally

5mg/80mg Tablet CADUET Pfizer Inc.3 Not available

locally

10 mg/10 mg

Tablet

ENVACAR /

NORVASC

PROTECT

Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-3146

(DR-XY30125)

10 mg/20 mg

Tablet

ENVACAR /

NORVASC

PROTECT

Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY30122

10mg/40mg

Tablet

CADUET Pfizer Inc.3 Not available

locally

10mg/80mg

Tablet

CADUET Pfizer Inc.3 Not available

locally

Amlodipine (as

besilate) + Benazepril

Hydrochloride

2.5mg/10mg

Capsule

LOTREL Novartis Pharmaceuticals

Corp.3

Not available

locally

5mg/10mg

Capsule

LOTREL Novartis Pharmaceuticals

Corp.3

Not available

locally

5mg/20mg

Capsule

LOTREL Novartis Pharmaceuticals

Corp.3

Not available

locally

5mg/40mg

Capsule

LOTREL Novartis Pharmaceuticals

Corp.3

Not available

locally

10mg/20mg

Capsule

LOTREL Novartis Pharmaceuticals

Corp.3

Not available

locally

10mg/40mg

Capsule

LOTREL Novartis Pharmaceuticals

Corp.3

Not available

locally

Amlodipine (as

besilate) +

5mg/12.5mg/20m

g Tablet

SEVIKAR HCT Daiichi Sankyo UK

Limited2

Not available

locally

Page 8:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

8

Hydrochlorothiazide+

Olmesartan

Medoxomil

TRIBENZOR Daiichi Sankyo Inc.3

5mg/12.5mg/40m

g Tablet

SEVIKAR HCT Daiichi Sankyo UK

Limited2

Not available

locally

TRIBENZOR Daiichi Sankyo Inc.3

5mg/25mg/40mg

Tablet

SEVIKAR HCT Daiichi Sankyo UK

Limited2

Not available

locally

TRIBENZOR Daiichi Sankyo Inc.3

10mg/12.5mg/40

mg Tablet

SEVIKAR HCT Daiichi Sankyo UK

Limited2

Not available

locally

TRIBENZOR Daiichi Sankyo Inc.3

10mg/25mg/40mg

Tablet

SEVIKAR HCT Daiichi Sankyo UK

Limited2

Not available

locally

TRIBENZOR Daiichi Sankyo Inc.3

Amlodipine (as

besilate) +

Hydrochlorothiazide+

Valsartan

5mg/12.5mg/160

mg Tablet

EXFORGE HCT Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica SA – Spain]

DRP-6803

5mg/25mg/160mg

Tablet

EXFORGE HCT Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica SA – Spain]

DRP-6807

10mg/12.5mg/160

mg Tablet

EXFORGE HCT Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica SA – Spain]

DRP-6804

10mg/25mg/160m

g Tablet

EXFORGE HCT Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica SA – Spain]

DRP-6805

10mg/25mg/320m

g Tablet

EXFORGE HCT Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica SA – Spain]

DRP-6806

Amlodipine (as

besilate) +

Olmesartan

Medoxomil

5mg/20mg Film-

Coated Tablet

NORMETEC Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DR-XY37885

5mg/40mg Film-

Coated Tablet

NORMETEC Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DR-XY37884

10mg/20mg

Tablet

AZOR Daiichi Sankyo Inc.3 Not available

locally

10mg/40mg

Tablet

SEVIKAR Daiichi Sankyo UK

Limited2

Not available

locally

AZOR Daiichi Sankyo Inc.3

Amlodipine (as

besilate) + Valsartan

5 mg/80 mg

Tablet

EXFORGE Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DRP-4862

(DR-XY34217)

5 mg/160 mg

Tablet

EXFORGE Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DRP-4869

(DR-XY34216)

5mg/320mg

Tablet

EXFORGE Novartis Pharmaceuticals

Corp.3

Not available

locally

Page 9:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

9

10 mg/160 mg

Tablet

EXFORGE Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DRP-4868

(DR-XY34218)

10mg/320mg

Tablet

EXFORGE Novartis Pharmaceuticals

Corp.3

Not available

locally

Amoxicillin (as

trihydrate)

250 mg Capsule AMOXIL GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-9037-L

500 mg Capsule AMOXIL GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DRP-6461

(DR-X1753-L)

100 mg/mL

Powder or

Granules for Oral

Suspension

AMOXIL GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-9035

125 mg/5 mL

Powder or

Granules for Oral

Suspension

AMOXIL GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-9036

250 mg/5 mL

Powder or

Granules for Oral

Suspension

AMOXIL

FORTE

GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DRP-6460

(DR-X6448-L)

Anagrelide (as

Hydrochloride)

500mcg Capsule AGRYLIN GenAsia Biotech L.L.

Corp. [DSM

Pharmaceutical Inc. -

USA]

DR-XY31450

Anastrozole 1 mg Tablet ARIMIDEX AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’ls LP – USA]

DR-XY24551

Apixaban ELIQUIS 2.5mg Tablet Pfizer, Inc. [Bristol-Myers

Squibb – Italy]

DR-XY42174

ELIQUIS 5mg Tablet Pfizer, Inc. [Bristol-Myers

Squibb – Italy]

DR-XY43189

Apremilast 10 mg Tablet OTEZLA Celgene2,3 Not available

locally

20 mg Tablet OTEZLA Celgene2,3 Not available

locally

30 mg Tablet OTEZLA Celgene2,3 Not available

locally

Aprepitant 40mg Capsule EMEND Merck and Co. Inc.3 Not available

locally

80mg Capsule EMEND Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Corp. –

Germany]

DR-XY31176

Page 10:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

10

Merck Sharp & Dohme

(I.A.) Corp. [Alkermes

Pharma Ireland Ltd. –

Ireland]

DR-XY44898

125mg Capsule EMEND Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Corp. –

Germany]

DR-XY31177

DR-XY41464

Merck Sharp & Dohme

(I.A.) Corp. [Alkermes

Pharma Ireland Ltd. –

Ireland]

DR-XY44899

125mg Powder for

Oral Suspension

EMEND Merck Sharp and Dohme

Limited2

Not available

locally

Merck Sharp and Dohme

Corp. a subsidiary of

Merck and Co. Inc.3

Aripiprazole 2mg Tablet ABILIFY Otsuka Pharmaceutical Co.

Ltd.3

Not available

locally

5mg Tablet ABILIFY Otsuka Phils. Pharm’l, Inc.

[Korea Otsuka Pharm’l

Co., Ltd. – Korea]

DRP-6282

(DR-XY32978)

10mg Tablet ABILIFY Otsuka Phils. Pharm’l, Inc.

[Korea Otsuka Pharm’l

Co., Ltd. – Korea]

DRP-6281

(DR-XY30931)

15mg Tablet ABILIFY Otsuka Phils. Pharm’l, Inc.

[Korea Otsuka Pharm’l

Co., Ltd. – Korea]

DRP-6283

(DR-XY30932)

20mg Tablet ABILIFY Otsuka Pharmaceutical Co.

Ltd.3

Not available

locally

30mg Tablet ABILIFY Otsuka Pharmaceuticals

(UK) Ltd.2

Not available

locally

Otsuka Pharmaceutical Co.

Ltd.3

10mg Orally

Disintegrating

Tablet

ABILIFY

DISCMELT

Otsuka Phils. Pharm’l, Inc.

[Bristol-Myers Squibb

Manufacturing Co. –

Puerto Rico]

DR-XY35464

ABILIFY

DISCMELT

Otsuka Phils. Pharm’l, Inc.

[Korea Otsuka

Pharmaceutical Co., Ltd.]

DR-XY45588

15mg Orally

Disintegrating

Tablet

ABILIFY

DISCMELT

Otsuka Phils. Pharm’l, Inc.

[Bristol-Myers Squibb

Manufacturing Co. –

Puerto Rico]

DR-XY35465

Page 11:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

11

ABILIFY

DISCMELT

Otsuka Phils. Pharm’l, Inc.

[Korea Otsuka

Pharmaceutical Co., Ltd.]

DR-XY45589

Armodafinil 50mg Tablet NUVIGIL Cephalon Inc.3 Not available

locally

150mg Tablet NUVIGIL Cephalon Inc.3 Not available

locally

200mg Tablet NUVIGIL Cephalon Inc.3 Not available

locally

250mg Tablet NUVIGIL Cephalon Inc.3 Not available

locally

Artemether +

Lumefantrine

20 mg/120 mg

Tablet

COARTEM

Novartis Healthcare Phils.,

Inc. [Beijing Novartis

Pharma Ltd. – China]

DR-XY25933

20 mg/120 mg

Dispersible Tablet

COARTEM

Dispersible

Novartis Healthcare Phils.,

Inc. [Novartis Pharm’ls

Corp. – USA]

DR-XY39663

Asenapine (as

Maleate)

2.5mg Sublingual

Tablet

SAPHRIS Forest Laboratories LLC3 Not available

locally

5mg Sublingual

Tablet

SAPHRIS Metro Drug Inc. [Organon

Ireland Ltd. – Ireland]

DR-XY38671

10mg Sublingual

Tablet

SAPHRIS Metro Drug Inc. [Organon

Ireland Ltd. – Ireland]

DR-XY38672

Atazanavir (as

Sulfate)

100mg Capsule REYATAZ Bristol-Myers Squibb

Pharamceutical Limited2

Not available

locally

150mg Capsule REYATAZ Bristol-Myers Squibb

Pharamceutical Limited2

Not available

locally

Bristol-Myers Squibb Co.3

200mg Capsule REYATAZ Bristol-Myers Squibb

Pharamceutical Limited2

Not available

locally

Bristol-Myers Squibb Co.3

300mg Capsule REYATAZ Bristol-Myers Squibb

Pharamceutical Limited2

Not available

locally

Bristol-Myers Squibb Co.3

50mg Oral

Powder

REYATAZ Bristol-Myers Squibb Co.3 Not available

locally

Atazanavir (as

Sulfate) + Cobicistat

300mg Tablet EVOTAZ Bristol-Myers Squibb

Pharamceutical Limited2

Not available

locally

Bristol-Myers Squibb Co.3

Atenolol 25mg Tablet TENORMIN Alvogen Malta Operations

Ltd.3

Not available

locally

50 mg Tablet TENORMIN AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

UK Ltd. – United

Kingdom]

DR-XY14043

100 mg Tablet TENORMIN AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

DR-XY14058

Page 12:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

12

UK Ltd. – United

Kingdom]

Atenolol +

Chlortalidone

50mg/25mg

Tablet

TENORETIC 50 Alvogen Malta Operations

Ltd.3

Not available

locally

50mg/12.5mg

Tablet

TENORETIC AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca UK Ltd.

– UK]

DR-XY14710

100mg/25mg

Tablet

TENORETIC AstraZeneca UK Limited2 Not available

locally TENORETIC

100

Alvogen Malta Operations

Ltd.3

Atomoxetine (as

Hydrochloride)

10mg Capsule STRATTERA Eli Lilly (Philippines) Inc.

[Lilly Del Caribe Inc. –

Spain]

DR-XY44611

18mg Capsule STRATTERA Eli Lilly (Philippines) Inc.

[Lilly Del Caribe Inc. –

Spain]

DR-XY44709

25mg Capsule STRATTERA Eli Lilly (Philippines) Inc.

[Lilly Del Caribe Inc. –

Spain]

DR-XY44710

40mg Capsule STRATTERA Eli Lilly (Philippines) Inc.

[Lilly Del Caribe Inc. –

Spain]

DR-XY44711

60mg Capsule STRATTERA Eli Lilly (Philippines) Inc.

[Lilly Del Caribe Inc. –

Spain]

DR-XY44610

80mg Capsule STRATTERA Eli Lilly and Company

Limited2

Not available

locally

Eli Lilly and Co.3

100mg Capsule STRATTERA Eli Lilly and Company

Limited2

Not available

locally

Eli Lilly and Co.3

Atorvastatin (as

calcium)

10 mg Tablet LIPITOR Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-3361

20 mg Tablet LIPITOR Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-3362

40 mg Tablet LIPITOR Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-3363

80 mg Tablet LIPITOR Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-3364

62.5mg/250mg

Tablet

MALANIL GlaxoSmithKline

Philippines, Inc.

DR-XY40333

Page 13:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

13

Atovaquone +

Proguanil

Hydrochloride

[GlaxoSmithKline Inc. –

Canada]

250mg/100mg

Tablet

MALANIL GlaxoSmithKline

Philippines, Inc.

[GlaxoSmithKline Inc. –

Canada]

DR-XY35390

Atropine sulfate

monohydrate +

Hyoscine

hydrobromide +

Hyoscyamine sulfate

dihydrate

19.4 mcg/6.5 mcg/

103.7 mcg Tablet

DONNATAB Pfizer, Inc. [Interphil

Labs., Inc.]

DR-XY31283

(For Export

Only)

Axitinib 1mg Tablet INLYTA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY43764

3mg Tablet INLYTA Pfizer Limited2 Not available

locally

5mg Tablet INLYTA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY43765

7mg Tablet INLYTA Pfizer Limited2 Not available

locally

Azathioprine 25mg Tablet IMURAN Aspen Trading – Ireland2 Not available

locally

50 mg Tablet IMURAN Aspen Phils., Inc. [Excella

GmbH – Germany]

DR-XY9450

Azilsartan

Medoxomil (as

Potassium)

20mg Tablet EDARBI Takeda UK Ltd.2 Not available

locally

40mg Tablet EDARBI Takeda Healthcare

Philippines, Inc. [Takeda

Pharmaceutical Company

Limited – Japan]

DR-XY41528

80mg Tablet EDARBI Takeda Healthcare

Philippines, Inc. [Takeda

Pharmaceutical Company

Limited – Japan]

DR-XY41529

Azilsartan

Medoxomil (as

Potassium) +

Chlortalidone

40mg/12.5mg

Tablet

EDARBYCLOR Takeda Healthcare

Philippines, Inc. DR-

XY[Takeda

Pharmaceutical Company

Limited – Japan]

DR-XY44713

40mg/25mg

Tablet

EDARBYCLOR Takeda Healthcare

Philippines, Inc. DR-

XY[Takeda

DR-XY44714

Page 14:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

14

Pharmaceutical Company

Limited – Japan]

Azithromycin (as

dihydrate)

250 mg Tablet ZITHROMAX Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-3379

(DR-XY16629)

500 mg Tablet ZITHROMAX Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-3366

(DR-XY26462)

600mg Tablet ZITHROMAX Pfizer Central Research3 Not available

locally

100 mg/5 mL

Powder for Oral

Suspension

ZITHROMAX Pfizer Chemicals Div.

Pfizer Inc.3

Not available

locally

200 mg/5 mL

Powder or

Granules for Oral

Suspension

ZITHROMAX Pfizer, Inc. [Haupt Pharma

Latina S.r.l. – Italy]

DRP-3367

(DR-XY16630)

1g Powder For

Oral Suspension

ZMAX Pfizer Central Research3 Not available

locally

2 g Extended

Release Powder

for Oral

Suspension

ZMAX ONE

DOSE

Pfizer, Inc. [Pfizer Pharm’l

LLC – Puerto Rico]

DR-XY31104

250mg Capsule ZITHROMAX Pfizer Limited2 Not available

locally

Azithromycin

monohydrate

250 mg Tablet AZYTH Sandoz Phils. Corp.

[Novartis Ltd. –

Bangladesh]

DRP-1285

500 mg Tablet AZYTH Sandoz Phils. Corp.

[Novartis Ltd. –

Bangladesh]

DRP-1286

200 mg/5 mL

Powder or

Granules for Oral

Suspension

AZYTH Sandoz Phils. Corp. [SC

Sandoz S.r.l – Romania]

DRP-1879

Baclofen 10 mg Tablet LIORESAL Novartis Healthcare Phils.,

Inc. [Novartis Farma

S.p.A. – Italy]

DR-X8065

20mg Tablet LIORESAL Novartis Pharmaceuticals

Corp.3

Not available

locally

Bambuterol

hydrochloride

10 mg Tablet BAMBEC AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co. Ltd. – China]

DR-XY23111

BAMBEC AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

AB – Sweden]

DR-XY39157

Page 15:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

15

Bedaquiline (as

Fumarate)

100mg Tablet SIRTURO Johnson & Johnson (Phils.)

Inc. [Kemwell Biopharma

Pvt. Ltd. – India]

DR-XY43795

Benazepril

Hydrochloride

5mg Tablet LOTENSIN US Pharmaceuticals

Holdings I LLC3

Not available

locally

10mg Tablet LOTENSIN US Pharmaceuticals

Holdings I LLC3

Not available

locally

CIBACEN Novartis Healthcare Phils.,

Inc. [Novartis Farma

S.P.A. – Italy]

DR-XY27740

20mg Tablet LOTENSIN US Pharmaceuticals

Holdings I LLC3

Not available

locally

40mg Tablet LOTENSIN US Pharmaceuticals

Holdings I LLC3

Not available

locally

Benazepril

Hydrochloride +

Hydrochlorthiazide

5mg/6.25mg

Tablet

LOTENSIN HCT US Pharmaceuticals

Holdings I LLC3

Not available

locally

10mg/12.5mg

Tablet

LOTENSIN HCT US Pharmaceuticals

Holdings I LLC3

Not available

locally

20mg/12.5mg

Tablet

LOTENSIN HCT US Pharmaceuticals

Holdings I LLC3

Not available

locally

20mg/25mg

Tablet

LOTENSIN HCT US Pharmaceuticals

Holdings I LLC3

Not available

locally

Beraprost (as sodium) 20mcg Tablet DORNER United Laboratories, Inc.

[Toray Industries, Inc. –

Japan]

DR-XY26797

60mcg Tablet CARELOAD Toray Industries, Inc.4 Not available

locally

BERASUS Kaken Pharmaceutical Co.,

Ltd.4

Not available

locally

Betahistine

hydrochloride

8 mg Tablet SERC Abbott Products Phils., Inc.

[Abbott Healthcare S.A.S.

– France]

DRP-472

(DR-10094)

16 mg Tablet SERC Abbott Products Phils., Inc.

[Abbott Healthcare S.A.S.

– France]

DRP-473

(DR-XY20691)

24 mg Tablet SERC Abbott Products Phils., Inc.

[Abbott Healthcare S.A.S.

– France]

DR-XY29111

SERC Abbott Products Phils., Inc.

[Mylan Laboratories S.A.S.

– France]

DRP-7104

Betahistine mesilate 6 mg Tablet MERISLON HI-Eisai Pharm’l, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY22029

12 mg Tablet MERISLON HI-Eisai Pharm’l, Inc.

[Eisai Co., Ltd. – Japan]

DR-XY28530

Page 16:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

16

Betamethasone 500 mcg Tablet

BETNELAN GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Bangladesh Ltd. –

Bangladesh]

DR-7689

CELESTONE Merck Sharp & Dohme

(I.A.) Corp. [PT. Schering-

Plough Indonesia Tbk. –

Indonesia]

DR-XY7133

Betamethasone +

Dexchlorpheniramine

maleate

250 mcg/2 mg

Tablet

CELESTAMINE Merck Sharp & Dohme

(I.A.) Corp. [PT. Merck

Sharp & Dohme Pharma

Tbk. – Indonesia]

DRP-6232

(DR-XY20881)

Bicalutamide 50 mg Tablet CASODEX AstraZeneca Pharm’ls

(Phils.), Inc. [Corden

Pharma GmbH – Germany]

DR-XY26042

150 mg Tablet CASODEX AstraZeneca Pharm’ls

(Phils.), Inc. [Corden

Pharma GmbH – Germany]

DR-XY27244

Bilastine 20mg Tablet BILAXTEN A. Menarini Philippines,

Inc. [A. Menarini

Manufacturing Logistics &

Services s.r.l. – Italy]

DR-XY43523

Biperiden

hydrochloride

2 mg Tablet AKINETON A. Menarini Phils., Inc.

[Abbott GmbH & Co. KG

– Germany

DR-8716

Bisacodyl 5mg Tablet DULCOLAX Boehringer Ingelheim

Phils., Inc. [Interphil

Laboratories, Inc.]

DR-1745

5mg Delayed-

Release Tablet

DULCOLAX Boehringer Ingelheim

(Phils.), Inc. [PT.

Boehringer Ingelheim

Indonesia – Indonesia]

DR-XY42393

Bisoprolol fumarate 2.5 mg Tablet CONCORE Merck, Inc. (Phils.) [Merck

KgaA – Germany]

DR-XY26678

5 mg Tablet CONCORE Merck, Inc. (Phils.) [PT.

Merck Tbk. – Indonesia]

DRP-6628

(DR-XY32829)

Merck, Inc. (Phils.) [Merck

KgaA – Germany]

10 mg Tablet CONCORE Merck, Inc. (Phils.) [Merck

KgaA – Germany]

DR-XY29470

Bisoprolol fumarate +

Hydrochlorothiazide

2.5 mg/6.25 mg

Tablet

ZIAC Merck, Inc. (Phils.) [PT.

Merck Tbk. – Indonesia]

DR-XY26004

Merck, Inc. (Phils.) [Merck

KgaA – Germany]

5 mg/6.25 mg

Tablet

ZIAC Merck, Inc. (Phils.) [Merck

KgaA – Germany]

DR-XY27281

Page 17:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

17

10 mg/6.25 mg

Tablet

ZIAC Merck, Inc. (Phils.) [Merck

KgaA – Germany]

DR-XY27280

Bosentan 62.5mg Tablet TRACLEER Actelion Pharmaceuticals

UK Ltd.2

Not available

locally

Actelion Pharmaceuticals

Ltd.3

125mg Tablet TRACLEER A. Menarini Philippines,

Inc. [Patheon Inc. –

Canada]

DR-XY30311

Bromhexine

hydrochloride

8 mg Tablet BISOLVON Boehringer Ingelheim

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-1144

BISOLVON Boehringer Ingelheim

(Phils.), Inc. [PT.

Boehringer Ingelheim

Indonesia – Indonesia]

DR-XY40886

16 mg Capsule BISOLVON

FORTE

Boehringer Ingelheim

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY27714

Bromocriptine (as

Mesilate)

2.5mg Tablet PARLODEL Novartis Healthcare Phils.

Inc. [Novartis Farma

S.p.A. – Italy]

DR-XY7404

Butamirate Citrate 50mg Sustained-

Release Tablet

SINECOD

FORTE

Novartis Healthcare

Philippines Inc. [Novartis

Saglik, Gida ve Tarim

Urunleri San. Ve Tic. A.S.

– Turkey]

DR-XY7110

Calcitriol 0.25 mcg Softgel

Capsule

ROCALTROL Roche (Phils.), Inc. [R.P.

Scherer GmbH & Co. KG

– Germany]

DR-XY28641

Canagliflozin (as

Hemihydrate)

100mg Tablet INVOKANA Johnson & Johnson (Phils.)

Inc. [Janssen Cilag SpA –

Italy]

DR-XY43830

300mg Tablet INVOKANA Johnson & Johnson (Phils.)

Inc. [Janssen Cilag SpA –

Italy]

DR-XY43830

Canagliflozin (as

Hemihydrate) +

Metformin

Hydrochloride

50mg/500mg

Tablet

VOKANAMET Janssen-Cilag Ltd.2 Not available

locally INVOKAMET Janssen Pharmaceuticals

Inc.3

50mg/850mg

Tablet

VOKANAMET Janssen-Cilag Ltd.2 Not available

locally

50mg/1g Tablet VOKANAMET Janssen-Cilag Ltd.2 Not available

locally INVOKAMET Janssen Pharmaceuticals

Inc.3

150mg/500mg

Tablet

VOKANAMET Janssen-Cilag Ltd.2 Not available

locally INVOKAMET Janssen Pharmaceuticals

Inc.3

Page 18:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

18

150mg/850mg

Tablet

VOKANAMET Janssen-Cilag Ltd.2 Not available

locally

150mg/1g Tablet VOKANAMET Janssen-Cilag Ltd.2 Not available

locally INVOKAMET Janssen Pharmaceuticals

Inc.3

50mg/500mg

Extended-Release

Tablet

INVOKAMET

XR

Janssen Pharmaceuticals

Inc.3

Not available

locally

50mg/1g

Extended-Release

Tablet

INVOKAMET

XR

Janssen Pharmaceuticals

Inc.3

Not available

locally

150mg/500mg

Extended-Release

Tablet

INVOKAMET

XR

Janssen Pharmaceuticals

Inc.3

Not available

locally

150mg/1g

Extended-Release

Tablet

INVOKAMET

XR

Janssen Pharmaceuticals

Inc.3

Not available

locally

Candesartan cilexetil 2mg Tablet AMIAS Takeda UK Ltd.2 Not available

locally

4mg Tablet AMIAS Takeda UK Ltd.2 Not available

locally ATACAND AstraZeneca

Pharmaceuticals LP3

8 mg Tablet BLOPRESS Takeda Pharm’ls (Phils.),

Inc. [Takeda Pharm’l Co.,

Ltd. – Japan]

DR-XY24550

16 mg Tablet BLOPRESS Takeda Pharm’ls (Phils.),

Inc. [Takeda Pharm’l Co.,

Ltd. – Japan]

DR-XY24549

32mg Tablet AMIAS Takeda UK Ltd.2 Not available

locally ATACAND AstraZeneca

Pharmaceuticals LP3

Candesartan cilexetil

+

Hydrochlorothiazide

16 mg/12.5 mg

Tablet

BLOPRESS

PLUS

Takeda Pharm’ls (Phils.),

Inc. [Takeda Italia

Farmaceutici S.p.A. –

Italy]

DR-XY27256

32mg/12.5mg

Tablet

ATACAND HCT AstraZeneca

Pharmaceuticals LP3

Not available

locally

32mg/25mg

Tablet

ATACAND HCT AstraZeneca

Pharmaceuticals LP3

Not available

locally

Capecitabine 150 mg Tablet XELODA Roche (Phils.), Inc.

[Productos Roche S.A. de

C.V. – Mexico]

DR-XY38088

500 mg Tablet XELODA Roche (Phils.), Inc.

[Productos Roche S.A. de

C.V. – Mexico]

DR-XY38089

Page 19:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

19

Captopril 25 mg Tablet CAPOTEN [Bristol-Myers Squibb

Australia Pty. Ltd. –

Australia]2,3

Not available

locally

Unbranded Ritemed Phils., Inc.

[United Labs., Inc.]

DR-XY33443

Unbranded Ritemed Phils., Inc.

[Sydenham Labs., Inc.]

DRP-166-01

50 mg Tablet CAPOTEN [Bristol-Myers Squibb

Australia Pty. Ltd. –

Australia]2,3

Not available

locally

Captopril +

Hydrochlorothiazide

25mg/15mg

Tablet

CAPOZIDE

25/15

Apothecon Inc Div Bristol

Myers Squibb3

Not available

locally

25mg/25mg

Tablet

CAPOZIDE

25/25

Apothecon Inc Div Bristol

Myers Squibb3

Not available

locally

50mg/15mg

Tablet

CAPOZIDE

50/15

Apothecon Inc Div Bristol

Myers Squibb3

Not available

locally

50mg/25mg

Tablet

CAPOZIDE E.R. Squibb & Sons

Limited2

Not available

locally

CAPOZIDE

50/25

Apothecon Inc Div Bristol

Myers Squibb3

Carbamazepine

100mg Chewable

Tablet

TEGRETOL Novartis Pharmaceuticals

Corp.3

Not available

locally

100mg Tablet TEGRETOL Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

200 mg Tablet TEGRETOL Novartis Healthcare Phils.,

Inc. [Zhejiang Jiuzhou

Pharm’l C., Ltd – China]

DR-XY23796

400mg Tablet TEGRETOL Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

100mg Extended-

Release Tablet

TEGRETOL Novartis Pharmaceuticals

Corp.3

Not available

locally

200 mg Sustained-

Release Tablet

TEGRETOL SR Novartis Healthcare Phils.,

Inc. [Zhejiang Jiuzhou

Pharm’l C., Ltd – China]

DR-XY12952

400 mg Sustained-

Release Tablet

TEGRETOL LA Novartis Healthcare Phils.,

Inc. [Zhejiang Jiuzhou

Pharm’l C., Ltd – China]

DR-XY12953

100 mg/5 mL Oral

Suspension

TEGRETOL Novartis Healthcare Phils.,

Inc. [Delpharma Huningue

S.A.S. – France]

DR-XY25233

100mg Extended-

Release Capsule

CARBATROL Shire Development Inc.3 Not available

locally

EQUETRO Validus Pharmaceuticals

Inc.3

Not available

locally

200mg Extended-

Release Capsule

CARBATROL Shire Development Inc.3 Not available

locally

Page 20:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

20

EQUETRO Validus Pharmaceuticals

Inc.3

Not available

locally

300mg Extended-

Release Capsule

CARBATROL Shire Development Inc.3 Not available

locally

EQUETRO Validus Pharmaceuticals

Inc.3

Not available

locally

Carbimazole 5mg Tablet NEO

MERCAZOLE

A. Menarini Phils., Inc.

[Cenexi S.A.S. – France]

DR-6345

20mg Tablet NEO

MERCAZOLE

A. Menarini Phils., Inc.

[Cenexi S.A.S. – France]

DR-XY7543

Carbocisteine 500 mg Capsule SOLMUX Westmont Pharm’ls, Inc.

[United Labs., Inc.]

DRHR-717

LOVISCOL Pfizer, Inc. [Interphil

Labs., Inc.]

DRHR-873

200 mg Chewable

Tablet

SOLMUX

CHEWTAB

Westmont Pharm’ls, Inc.

[United Labs., Inc.]

DRHR-1487

500 mg Chewable

Tablet

SOLMUX

CHEWTAB

Westmont Pharm’ls, Inc.

[United Labs., Inc.]

DRHR-1488

100 mg/5 mL Oral

Suspension

SOLMUX Westmont Pharm’ls, Inc.

[United Labs., Inc.]

DRHR-752

200 mg/5 mL Oral

Suspension

SOLMUX Westmont Pharm’ls, Inc.

[United Labs., Inc.]

DRHR-718

SOLMUX Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DRHR-1398

250 mg/5 mL Oral

Suspension

ROBIKIDS Pfizer, Inc. [Interphil

Labs., Inc.]

DRHR-1051

500 mg/5 mL Oral

Suspension

SOLMUX

FORTE

Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DRHR-720

Carvedilol 3.125mg Tablet COREG SmithKline Beecham

(Cork) Ltd. Ireland3

Not available

locally

6.25 mg Tablet DILATREND Roche (Phils.), Inc. [Roche

S.p.A. – Italy]

DR-XY25988

12.5mg Tablet COREG SmithKline Beecham

(Cork) Ltd. Ireland3

Not available

locally

25 mg Tablet DILATREND Roche (Phils.), Inc. [Roche

S.p.A. – Italy]

DR-XY22130

Carvedilol Phosphate 10mg Extended-

Release Capsule

COREG CR SmithKline Beecham

(Cork) Ltd. Ireland3

Not available

locally

20mg Extended-

Release Capsule

COREG CR SmithKline Beecham

(Cork) Ltd. Ireland3

Not available

locally

40mg Extended-

Release Capsule

COREG CR SmithKline Beecham

(Cork) Ltd. Ireland3

Not available

locally

80mg Extended-

Release Capsule

COREG CR SmithKline Beecham

(Cork) Ltd. Ireland3

Not available

locally

Cefaclor 250 mg Capsule XELENT Westmont Pharm’ls, Inc.

[Asian Antibiotics, Inc.]

DR-XY25749

Page 21:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

21

500 mg Capsule CECLOR Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-X8594

XELENT Westmont Pharm’ls, Inc.

[Asian Antibiotics, Inc.]

DR-XY25753

50 mg/mL Powder

or Granules for

Oral Suspension

CECLOR Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-XY18121

125 mg/5 mL

Powder or

Granules for Oral

Suspension

CECLOR Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-X8596

250 mg/5 mL

Powder or

Granules for Oral

Suspension

CECLOR-DS Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-XY4009-L

Cefadroxil 500 mg Capsule DURICEF/

DURACEF/

ULTRACEF

[Bristol-Myers Squibb]/

Warner Chilcott Inc.3

Not available

locally

125 mg/5 mL

Powder for Oral

Suspension

DURICEF/

DURACEF/

ULTRACEF

[Bristol-Myers Squibb]/

Warner Chilcott Inc.3

Not available

locally

250 mg/5 mL

Powder for Oral

Suspension

DURICEF/

DURACEF/

ULTRACEF

[Bristol-Myers Squibb]/

Warner Chilcott Inc.3

Not available

locally

500 mg/5 mL

Powder for Oral

Suspension

DURICEF/

DURACEF/

ULTRACEF

[Bristol-Myers Squibb]/

Warner Chilcott Inc.3

Not available

locally

1g Tablet DURICEF Warner Chilcott Inc.3 Not available

locally

Cefalexin (as

monohydrate)

250 mg Capsule CEPOREX GlaxoSmithKline Phils.,

Inc. [Interphil Labs., Inc.]

DR-6865-L

500 mg Capsule CEPOREX GlaxoSmithKline Phils.,

Inc. [Interphil Labs., Inc.]

DRP-6496

(DR-6866-L)

750mg Capsule KEFLEX Pragma Pharmaceuticals

LLC3

Not available

locally

100 mg/mL

Powder or

Granules for Oral

Suspension

CEPOREX GlaxoSmithKline Phils.,

Inc. [Interphil Labs., Inc.]

DR-XY2819

125 mg/5 mL

Powder or

Granules for Oral

Suspension

CEPOREX GlaxoSmithKline Phils.,

Inc. [Interphil Labs., Inc.]

DR-9609-L

250 mg/5 mL

Powder or

Granules for Oral

Suspension

CEPOREX GlaxoSmithKline Phils.,

Inc. [Interphil Labs., Inc.]

DRP-6495

(DR-XY3906)

Page 22:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

22

Cefdinir 300mg Capsule OMNICEF Pfizer/Abbvie Inc.3 Not available

locally

125 mg /5 mL

Powder/Granules

for Oral

Suspension

OMNICEF Pfizer (Thailand) Ltd.

[Interphil Labs., Inc.]

DR-XY38958

(For Export

Only)

This product should be purchased in Thailand where the product

is exported to by the local manufacturer; otherwise this reference

product should be purchased from a well regulated market with a

stringent regulatory authority (SRA).

250 mg /5 mL

Powder/Granules

for Oral

Suspension

OMNICEF Abbvie Inc.3 Not available

locally

Cefixime 100 mg Capsule TERGECEF United American Pharm’ls,

Inc. [Asian Antibiotics,

Inc.]

DR-XY15861

200 mg Capsule TERGECEF United American Pharm’ls,

Inc. [Asian Antibiotics,

Inc.]

DR-XY16196

400 mg Capsule TERGECEF OD United American Pharm’ls,

Inc. [Asian Antibiotics,

Inc.]

DR-XY35403

SUPRAX Lupin Ltd.3 Not available

locally

20 mg/mL Powder

or Granules for

Oral Suspension

(Drops)

TERGECEF United American Pharm’ls,

Inc. [Asian Antibiotics,

Inc.]

DR-XY16858

100 mg/5 mL

Powder or

Granules for Oral

Suspension

TERGECEF United American Pharm’ls,

Inc. [Asian Antibiotics,

Inc.]

DR-XY16177

200mg/5mL

Powder for Oral

Suspension

SUPRAX Lupin Pharmaceuticals

Inc.3

Not available

locally

500mg/5mL

Powder for Oral

Suspension

SUPRAX Lupin Ltd.3 Not available

locally

200mg Tablet SUPRAX Sanofi2 Not available

locally

400mg Tablet SUPRAX Lupin Ltd.3 Not available

locally

200mg Chewable

Tablet

SUPRAX Lupin Ltd.3 Not available

locally

Cefpodoxime proxetil 100 mg Tablet BANAN PL Asia Pacific Phils., Inc.

[Shanghai Sankyo

Pharm’ls Co. Ltd. – China]

DR-XY25947

Page 23:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

23

ORELOX Sanofi-Aventis2 Not available

locally

VANTIN Pharmacia and Upjohn

Co.3

Not available

locally

200mg Tablet ORELOX Sanofi-Aventis2 Not available

locally

VANTIN Pharmacia and Upjohn

Co.3

Not available

locally

CEFPODOXIME

PROXETIL

Sandoz Inc.3 Not available

locally

40mg/5mL

Powder or

Granules for Oral

Suspension

ORELOX Sanofi-Aventis2 Not available

locally

50mg/5mL

Powder or

Granules for Oral

Suspension

VANTIN Pharmacia and Upjohn

Co.3

Not available

locally

100mg/5mL

Powder or

Granules for Oral

Suspension

VANTIN Pharmacia and Upjohn

Co.3

Not available

locally

CEFPODOXIME

PROXETIL

Sandoz Inc.3 Not available

locally

Capsule

Either one of the abovementioned products should be used as

comparator drug in the conduct of in vivo bioequivalence

studies.

Cefradine 125mg/5mL

Powder for

Suspension

VELOSEF Bristol Myers-Squibb2,3 Not available

locally

250mg/5mL

Powder for

Suspension

VELOSEF Bristol Myers-Squibb2,3 Not available

locally

250mg Capsule VELOSEF Bristol Myers-Squibb2,3 Not available

locally

500mg Capsule VELOSEF Bristol Myers-Squibb2,3 Not available

locally

Ceftibuten 200 mg Capsule CEDAX Merck Sharp & Dohme

(I.A.) Corp. [Societa

Industria Farmaceutica

Italiana (S.I.F.I.) S.p.A. –

Italy]

DR-XY16284

400mg Capsule CEDAX Pernix Therapeutics LLC3 Not available

locally

90mg/5mL

Powder for

Suspension

CEDAX Pernix Therapeutics LLC3 Not available

locally

Page 24:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

24

180mg/5mL

Powder for

Suspension

CEDAX Pernix Therapeutics LLC3 Not available

locally

Cefuroxime (as

axetil)

250 mg Tablet ZINACEF GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Operations UK Ltd. –

United Kingdom]

DR-XY10186

ZINNAT Duncan Pharm’ls Phils.,

Inc. [Glaxo Wellcome

Operations UK Ltd. –

United Kingdom]

DR-XY18370

500 mg Tablet ZINACEF GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Operations UK Ltd. –

United Kingdom]

DRP-6747

(DR-XY18354)

ZINNAT Duncan Pharm’ls Phils.,

Inc. [Glaxo Wellcome

Operations UK Ltd. –

United Kingdom]

DR-XY18371

125 mg/5 mL

Powder or

Granules for Oral

Suspension

ZINNAT Duncan Pharm’ls Phils.,

Inc. [Glaxo Wellcome

Operations UK Ltd. –

United Kingdom]

DR-XY14535

250 mg/5 mL

Powder or

Granules for Oral

Suspension

ZINNAT Duncan Pharm’ls Phils.,

Inc. [Glaxo Wellcome

Operations UK Ltd. –

United Kingdom]

DR-XY23360

125 mg Powder or

Granules for Oral

Suspension

ZINNAT Duncan Pharm’ls Phils.,

Inc. [Glaxo Operations UK

Ltd. – United Kingdom]

DR-XY43213

(in sachet)

250 mg Powder or

Granules for Oral

Suspension

ZINNAT Duncan Pharm’ls Phils.,

Inc. [Glaxo Operations UK

Ltd. – United Kingdom]

DR-XY44381

(in sachet)

Celecoxib 50mg Capsule CELEBREX GD Searle LLC3 Not available

locally

100 mg Capsule CELEBREX Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-2056

200 mg Capsule CELEBREX Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-2052

400 mg Capsule CELEBREX 400 Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-2057

Cetirizine

hydrochloride

10 mg Tablet VIRLIX GlaxoSmithKline Phils.,

Inc. [UCB Farchim SA –

Switzerland]

DR-XY13333

Page 25:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

25

ZYRTEC Duncan Pharm’l Phils.,

Inc. [UCB Farchim SA –

Switzerland]

DR-XY19582

Chloramphenicol 250 mg Capsule CHLOROMYC

ETIN

Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2070

500 mg Capsule CHLOROMYC

ETIN

Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2102

Chloramphenicol

palmitate

125 mg/5 mL Oral

Suspension

CHLOROMYC

ETIN

Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-3411

PEDIACHLOR Pediatrica, Inc. [Amherst

Labs., Inc.]

DR-8773

Chloroquine (as

Phosphate)

300mg Tablet ARALEN Sanofi-Aventis US LLC3 Not available

locally

Chlorphenamine

maleate

4 mg Tablet ANTAMIN Pascual Labs., Inc.

[Pascual Labs., Inc.]

DR-2359

Chlorphenamine

maleate +

Phenylpropanolamine

hydrochloride

2 mg/25 mg Tablet NOXIFEN Interhealthcare Pharm’ls

Inc. [Lloyd Labs., Inc.]

DRP-935

(DR-XY30089)

Chlorphenamine

maleate +

Phenylpropanolamine

hydrochloride +

Paracetamol

2 mg/20 mg/500

mg Capsule

EXTRA

STRENGTH

SINUTAB

Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY2346

2 mg/20 mg/325

mg Capsule

VEDECONT Philippine Home Pharm’ls

[Lloyd Labs., Inc.]

DR-XY31368

1 mg/20 mg/325

mg Tablet

NAFARIN-A United American Pharm’ls,

Inc. [Amherst Labs., Inc.]

DR-5832

2 mg/25 mg/500

mg Tablet

DECOLGEN

FORTE

(For Export

Only)

Westmont Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY3624

Chlorphenamine

maleate +

Phenylephrine

hydrochloride +

Paracetamol

2 mg/10 mg/500

mg Tablet

DECOLGEN Westmont Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY29386

DECOLGEN

FORTE

Westmont Pharm’ls, Inc.

[PT. Medifarma Labs. –

Indonesia]

DR-XY41124

NEOZEP

FORTE

Myra Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY29559

NEOZEP

FORTE

Myra Pharm’ls, Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY41125

BIOFLU Biomedis, Inc. [United

Labs., Inc.]

DR-XY34482

500 mcg/2.5

mg/125 mg per 5

mL Oral

Suspension

BIOFLU Biomedis, Inc. [Amherst

Labs., Inc.]

DR-XY37402

NEOZEP Myra Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY42507

Page 26:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

26

Chlorphenamine

maleate +

Dextromethorphan

hydrobromide +

Phenylpropanolamine

hydrochloride +

Guaifenesin

2 mg/10 mg/25

mg/50 mg Capsule

MUCOBRON

FORTE

Medi-Rx, Inc. [Medi-Rx,

Inc.]

DR-XY33008

Chlorphenamine

maleate +

Dextromethorphan

hydrobromide +

Phenylpropanolamine

hydrochloride +

Guaifenesin +

Paracetamol

1 mg/15 mg/30

mg/50 mg/325 mg

Capsule

DYNATUSSIN Crisdy-Na Drug Corp.

[Swisspharma Research

Labs., Inc.]

DR-XY18308

Chlorphenamine

maleate +

Phenylpropanolamine

hydrochloride +

Salicylamide +

Paracetamol

2 mg/25 mg/150

mg/325 mg Tablet

YK ANTAMIN Pascual Labs., Inc.

[Pascual Labs., Inc.]

DR-XY35895

Chlorpromazine

Hydrochloride

10mg Tablet LARGACTIL/

HIBERNAL

Sanofi-Aventis2 Not available

locally

THORAZINE GlaxoSmithKline3

25mg Tablet LARGACTIL/

HIBERNAL

Sanofi-Aventis2 Not available

locally

THORAZINE GlaxoSmithKline3

50mg Tablet LARGACTIL/

HIBERNAL

Sanofi-Aventis2 Not available

locally

THORAZINE GlaxoSmithKline3

100 mg Tablet THORAZINE GlaxoSmithKline3 Not available

locally

LARACTYL Natrapharm, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY20215

200 mg Tablet THORAZINE GlaxoSmithKline3 Not available

locally

LARACTYL Natrapharm, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY20207

Ciclosporin 10mg Softgel

Capsule

NEORAL Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

25 mg

Softgel Capsule

SANDIMMUN

NEORAL

Novartis Healthcare Phils.,

Inc. [Catalent Germany

Eberbach GmbH –

Germany]

DR-XY19305

Page 27:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

27

50mg Softgel

Capsule

NEORAL Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

100 mg Softgel

Capsule

SANDIMMUN

NEORAL

Novartis Healthcare Phils.,

Inc. [Catalent Germany

Eberbach GmbH –

Germany]

DR-XY19307

Cilostazol 50 mg Tablet PLETAAL Otsuka (Phils.) Pharm’l,

Inc. [Korea Otsuka

Pharm’l Co., Ltd. – Korea]

DR-XY35875

100 mg Tablet PLETAAL Otsuka (Phils.) Pharm’l,

Inc. [Korea Otsuka

Pharm’l Co., Ltd. – Korea]

DR-XY35877

Cimetidine 200mg Tablet TAGAMET GlaxoSmithKline Phils.

Inc. [SmithKline Beecham]

DR-X2744

400mg Tablet TAGAMET Chemidex Pharma Ltd.2 Not available

locally

Cinacalcet (as

hydrochloride)

25 mg Tablet REGPARA A. Menarini Phils., Inc.

[Ohara Pharm’l Co., Ltd. –

Japan]

DR-XY43544

30 mg Tablet MIMPARA Amgen Ltd.2 Not available

locally SENSIPAR Amgen Inc.3

60 mg Tablet MIMPARA Amgen Ltd.2 Not available

locally SENSIPAR Amgen Inc.3

90 mg Tablet MIMPARA Amgen Ltd.2 Not available

locally SENSIPAR Amgen Inc.3

Cinnarizine 25 mg Tablet STUGERON Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY15279

STUGERON Johnson & Johnson

(Phils.), Inc. [Janssen

Korea Ltd. – Korea]

DR-XY34825

75 mg Capsule STUGERON

FORTE

Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-X548

STUGERON

FORTE

Johnson & Johnson

(Phils.), Inc. [Janssen

Korea Ltd. – Korea]

DR-XY40786

Ciprofloxacin (as

hydrochloride)

100mg Tablet CIPRO Bayer Healthcare

Pharmaceuticals Inc.3

Not available

locally

250 mg Tablet CIPROBAY Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY35879

500 mg Tablet CIPROBAY Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DRP-7194

(DR-XY34929)

750mg Tablet CIPROXIN Bayer plc2 Not available

locally CIPRO Bayer Healthcare

Pharmaceuticals Inc.3

Page 28:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

28

500 mg Extended-

Release Tablet

CIPROBAY XR Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY29458

1 g Extended-

Release Tablet

CIPROBAY XR Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY31382

250mg/5mL

Powder for Oral

Suspension

CIPROXIN Bayer plc2 Not available

locally CIPRO Bayer Healthcare

Pharmaceuticals Inc.3

500mg/5mL

Powder for Oral

Suspension

CIPRO Bayer Healthcare

Pharmaceuticals Inc.3

Not available

locally

Citalopram (as

Hydrobromide)

10mg Tablet CIPRAMIL Lundbeck Limited2 Not available

locally CELEXA Forest Laboraties Inc.3

20mg Tablet CIPRAMIL Lundbeck Limited2 Not available

locally CELEXA Forest Laboraties Inc.3

40mg Tablet CIPRAMIL Lundbeck Limited2 Not available

locally CELEXA Forest Laboraties Inc.3

Citicoline (as

Sodium)

500 mg Capsule SOMAZINE Patriot Pharm’ls Corp.

[Hizon Labs., Inc.]

DRP-432

500 mg Tablet CHOLINERV Therapharma, Inc.

[Amherst Labs., Inc.]

DR-XY33845

1g Tablet CHOLINERV Unilab, Inc. [Amherst

Labs., Inc.]

DR-XY44609

Clarithromycin 250 mg Tablet KLARICID Abbott Labs. [PT. Abbott

Indonesia – Indonesia]

DR-XY39261

500 mg Tablet KLARICID Abbott Labs. [PT. Abbott

Indonesia – Indonesia]

DRP-4594

(DR-XY40032)

500 mg Extended-

Release Tablet

KLARICID OD Abbott Labs. [Aesica

Queenborough Ltd. –

United Kingdom]

DRP-1290

(DR-XY24276)

125 mg/5 mL

Powder or

Granules for Oral

Suspension

KLARICID Abbott Labs. [PT. Abbott

Indonesia – Indonesia]

DRP-1916

250 mg/5 mL

Powder or

Granules for Oral

Suspension

KLARICID Abbott Labs. [PT. Abbott

Indonesia – Indonesia]

DRP-2199

Clemastine (as

fumarate)

1 mg Tablet TAVEGYL Novartis Healthcare Phils.,

Inc. [Novartis Pharma

GmbH – Germany]

DR-4609

Clindamycin (as

hydrochloride)

75mg Capsule CLEOCIN

HYDROCHLOR

IDE

Pharmacia and Upjohn

Co.3

Not available

locally

150 mg Capsule DALACIN C Pfizer, Inc. [PT. Pfizer

Indonesia – Indonesia]

DRP-1954

Page 29:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

29

300 mg Capsule DALACIN C Pfizer, Inc. [PT. Pfizer

Indonesia – Indonesia]

DRP-1953

Clobazam 10mg Tablet FRISIUM Sanofi2 Not available

locally

ONFI Lundbeck Pharmaceuticals

LLC3

Not available

locally

20mg Tablet ONFI Lundbeck Pharmaceuticals

LLC3

Not available

locally

2.5mg/mL

Suspension

ONFI Lundbeck Pharmaceuticals

LLC3

Not available

locally

Clomifene citrate 50 mg Tablet CLOMID Sanofi-Aventis Phils., Inc.

[Patheon Pharm’ls, Inc. –

USA]

DR-5192

Clonazepam

500 mcg Tablet KLONOPIN Hoffman La Roche Inc.3 Not available

locally

1mg Tablet KLONOPIN Hoffman La Roche Inc.3 Not available

locally

2 mg Tablet RIVOTRIL Roche (Phils.), Inc.

[Roche Farma S.A. –

Spain]

DR-XY37012

Clonidine

Hydrochloride

75mcg Tablet CATAPRES Boehringer Ingelheim

(Phil.), Inc.

DR-X602

100mcg Tablet CATAPRES Boehringer Ingelheim

Limited2

Not available

locally

CATAPRES Boehringer Ingelheim3

150mcg Tablet CATAPRES Boehringer Ingelheim

(Phil.), Inc.

DR-8015

200mcg Tablet CATAPRES Boehringer Ingelheim3 Not available

locally

300mcg Tablet CATAPRES Boehringer Ingelheim3 Not available

locally

100mcg Extended-

Release Tablet

KAPVAY Concordia Pharmaceuticals

Inc.3

Not available

locally

Clopidogrel bisulfate 75 mg Tablet PLAVIX Sanofi-Aventis Phils., Inc.

[Sanofi Winthrop Industrie

– France]

DRP-5643

(DR-XY24856)

300 mg Tablet PLAVIX Sanofi-Aventis Phils., Inc.

[Sanofi Winthrop Industrie

– France]

DR-XY37405

Clorazepate

Dipotassium

5mg Capsule TRANXENE Sanofi-Aventis Philippines,

Inc. [Sanofi-Aventis S.A. –

Pain]

DR-X1254

7.5mg Capsule TRANXENE Recordati Rare Diseases

Inc.3

Not available

locally

15mg Capsule TRANXENE Recordati Rare Diseases

Inc.3

Not available

locally

Page 30:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

30

Cloxacillin (as

sodium)

250 mg Capsule CLOXAPEN GlaxcoSmithKline3 Not available

locally

500 mg Capsule ORBENIN GlaxcoSmithKline2 Not available

locally CLOXAPEN GlaxcoSmithKline3

1g Capsule ORBENIN GlaxcoSmithKline2 Not available

locally

125 mg/5 mL

Powder or

Granules for Oral

Suspension

ORBENIN GlaxcoSmithKline2 Not available

locally

Clozapine 25 mg Tablet LEPONEX Novartis Healthcare Phils.,

Inc. [Novartis Saglik –

Turkey]

DR-XY18407

100 mg Tablet LEPONEX Novartis Healthcare Phils.,

Inc. [Novartis Pharm’ls

UK Ltd. – United

Kingdom]

DR-XY18403

50mg/mL

Suspension

VERSACLOZ Jazz Pharmaceuticals

International III3

Not available

locally

12.5mg Orally

Disintegrating

Tablet

FAZACLO ODT Jazz Pharmaceuticals

International III3

Not available

locally

25mg Orally

Disintegrating

Tablet

FAZACLO ODT Jazz Pharmaceuticals

International III3

Not available

locally

100mg Orally

Disintegrating

Tablet

FAZACLO ODT Jazz Pharmaceuticals

International III3

Not available

locally

150mg Orally

Disintegrating

Tablet

FAZACLO ODT Jazz Pharmaceuticals

International III3

Not available

locally

200mg Orally

Disintegrating

Tablet

FAZACLO ODT Jazz Pharmaceuticals

International III3

Not available

locally

Co-Amoxiclav

(Amoxicillin +

Clavulanic Acid)

250 mg/125 mg

Tablet

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

Plc. – United Kingdom]

DR-XY34001

500 mg/125 mg

Tablet

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

Plc. – United Kingdom]

DR-XY14796

875 mg/125 mg

Tablet

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

Plc. – United Kingdom]

DR-XY23156

1g/62.5mg

Sustained-Release

Tablet

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-XY44471

Page 31:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

31

50mg/12.5mg per

mL Powder for

Oral Suspension

(Infant Drops)

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

Pharmaceutical – United

Kingdom]

DR-XY43534

125 mg/31.25 mg

per 5 mL Powder

for Oral

Suspension

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-XY14007

200 mg/28.5 mg

per 5 mL Powder

for Oral

Suspension

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

Plc. – United Kingdom]

DR-XY24085

250 mg/62.5 mg

per 5 mL Powder

for Oral

Suspension

AUGMENTIN

DS

GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-XY14008

400 mg/57 mg per

5 mL Powder for

Oral Suspension

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

Plc. – United Kingdom]

DR-XY23806

400 mg/57 mg

Powder for Oral

Suspension

(Sachet)

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

Plc. – United Kingdom]

DR-XY23806

500mg/125mg

Powder for Oral

Suspension

(Sachet)

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-XY44422

600 mg/42.9 mg

per 5 mL Powder

for Oral

Suspension

AUGMENTIN

ES

GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-XY32295

875mg/125mg

Powder for Oral

Suspension

(Sachet)

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-XY43809

1g/125mg Powder

for Oral

Suspension

(Sachet)

AUGMENTIN GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-XY43680

Colchicine 500 mcg Tablet Unbranded Philusa Corp. [Surepharm

Services Ltd. – United

Kingdom]

DR-X2619

600mcg Tablet COLCRYS Takeda Pharmaceuticals

Usa Inc.3

Not available

locally

600mcg Capsule MITIGARE Hikma International

Pharmaceuticals LLC3

Not available

locally

Page 32:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

32

Cotrimazine

(Sulfadiazine +

Trimethoprim)

820 mg/180 mg

Tablet

TRIZINE

FORTE

Phoenix Pharm’ls, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY24055

205 mg/45 mg per

5 mL Oral

Suspension

TRIZINE Phoenix Pharm’ls, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY21983

Cotrimoxazole

(Trimethoprim +

Sulfamethoxazole)

400 mg/80 mg

Tablet

BACTRIM Roche (Phils.), Inc.

[Interphil Labs., Inc.]

DR-75

BACTRIM Roche (Phils.), Inc.

[Productos Roche S.A. de

C.V. – Mexico]

DR-XY40457

800 mg/160 mg

Tablet

BACTRIM

FORTE

Roche (Phils.), Inc.

[Interphil Labs., Inc.]

DR-X2884

BACTRIM

FORTE

Roche (Phils.), Inc.

[Productos Roche S.A. de

C.V. – Mexico]

DR-XY40456

200 mg/40 mg per

5 mL Oral

Suspension

BACTRIM Roche (Phils.), Inc.

[Interphil Labs., Inc.]

DR-XY8083

400mg/80mg per

5mL Oral

Suspension

SEPTRIN Aspen2 Not available

locally

Cycloserine 250mg Capsule SEROMYCIN Purdue GMP Center LLC

dba The Chao Center

Industrial Pharmacy3

Not available

locally

Cyproterone acetate 50 mg Tablet ANDROCUR Bayer Phils., Inc.

[Delpharm Lille S.A.S. –

France]

DR-XY38963

Cyproterone acetate +

Ethinylestradiol

2 mg/35 mcg

Tablet

DIANE 35 Bayer Phils., Inc. [Schering

GmbH und Co.

Produktions KG –

Germany]

DR-XY6690

Dabigatran etexilate 75mg Capsule PRADAXA Boehringer Ingelheim

(Phils.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY35372

110mg Capsule PRADAXA Boehringer Ingelheim

(Phils.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY35371

150mg Capsule PRADAXA Boehringer Ingelheim

(Phils.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY39217

Dabrafenib (as

Mesilate)

50mg Capsule TAFINLAR Novartis Healthcare

Philippines, Inc. [Glaxo

Operations UK Limited]

DR-XY44999

Page 33:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

33

75mg Capsule TAFINLAR Novartis Healthcare

Philippines, Inc. [Glaxo

Operations UK Limited]

DR-XY44998

Daclatasvir (as

Dihydrochloride)

30mg Tablet DAKLINZA Bristol-Myers Squibb

Pharma EEIG2

Not available

locally

Bristol-Myers Squibb Co.3

60mg Tablet DAKLINZA Bristol-Myers Squibb

Pharma EEIG2

Not available

locally

Bristol-Myers Squibb Co.3

90mg Tablet DAKLINZA Bristol-Myers Squibb Co.3 Not available

locally

Danazol 50mg Capsule DANOCRINE/

DANOL

Sanofi2,3 Not available

locally

100mg Capsule DANOCRINE/

DANOL

Sanofi2,3 Not available

locally

200mg Capsule LADOGAL Sanofi-Aventis Philippines,

Inc. [Sanofi Synthelabo

Ltd. – United Kingdom]

DR-X3593

Dapagliflozin (as

Propanediol)

5mg Tablet FORXIGA AstraZeneca

Pharmaceuticals (Phils.)

Inc. [Bristol-Myers Squibb

– USA]

DR-XY43170

10mg Tablet FORXIGA AstraZeneca

Pharmaceuticals (Phils.)

Inc. [Bristol-Myers Squibb

– USA]

DR-XY43171

Dapagliflozin (as

Propanediol) +

Metformin

Hydrochloride

5mg/500mg Tablet XIGDUO XR AstraZeneca

Pharmaceuticals (Phils.)

Inc. [Bristol-Myers Squibb

Manufacturing Company –

Puerto Rico]

DR-XY44970

5mg/850mg Tablet XIGDUO AstraZeneca UK Limited2 Not available

locally

5mg/1g Tablet XIGDUO XR AstraZeneca

Pharmaceuticals (Phils.)

Inc. [Bristol-Myers Squibb

Manufacturing Company –

Puerto Rico]

DR-XY44971

10mg/500mg

Tablet

XIGDUO XR AstraZeneca

Pharmaceuticals (Phils.)

Inc. [Bristol-Myers Squibb

Manufacturing Company –

Puerto Rico]

DR-XY44972

10mg/1g Tablet XIGDUO XR AstraZeneca

Pharmaceuticals (Phils.)

Inc. [Bristol-Myers Squibb

DR-XY44973

Page 34:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

34

Manufacturing Company –

Puerto Rico]

Dapagliflozin (as

Propanediol) +

Saxagliptin (as

Hydrochloride)

10mg/5g Tablet QTERN AstraZeneca UK Limited2 Not available

locally AstraZeneca AB3

Dapoxetine (as

Hydrochloride)

30mg Film-Coated

Tablet

PRILIGY A. Menarini Phils., Inc.

[Janssen Ortho LLC –

Puerto Rico]

DR-XY37906

60mg Film-Coated

Tablet

PRILIGY A. Menarini Phils., Inc.

[Janssen Ortho LLC –

Puerto Rico]

DR-XY37907

Darifenacin (as

Hydrobromide)

7.5mg Prolonged-

Release Tablet

ENABLEX Aspen Philippines, Inc.

[Novartis Pharma Stein AG

– Switzerland]

DR-XY33826

15mg Prolonged-

Release Tablet

ENABLEX Aspen Philippines, Inc.

[Novartis Pharma Stein AG

– Switzerland]

DR-XY33797

Deferasirox 125mg Tablet for

Oral Suspension

EXJADE Novartis Pharmaceuticals

Corp.3

Not available

locally

250mg Dispersible

Tablet

EXJADE Novartis Healthcare Phils.

Inc. [Novartis Pharma

Stein AG – Switzerland]

DR-XY32444

250mg Tablet for

Oral Suspension

EXJADE Novartis Pharmaceuticals

Corp.3

Not available

locally

500mg Tablet for

Oral Suspension

EXJADE Novartis Pharmaceuticals

Corp.3

Not available

locally

90mg Oral

Granule

JADENU

SPRINKLE

Novartis Pharmaceuticals

Corp.3

Not available

locally

180mg Oral

Granule

JADENU

SPRINKLE

Novartis Pharmaceuticals

Corp.3

Not available

locally

360mg Oral

Granule

JADENU

SPRINKLE

Novartis Pharmaceuticals

Corp.3

Not available

locally

90mg Tablet EXJADE Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

JADENU Novartis Pharmaceuticals

Corp.3

180mg Tablet EXJADE Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

JADENU Novartis Pharmaceuticals

Corp.3

360mg Tablet EXJADE Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

JADENU Novartis Pharmaceuticals

Corp.3

Page 35:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

35

Desloratadine 5 mg Tablet AERIUS Merck Sharp & Dohme

(I.A.) Corp. [Schering-

Plough S.p.A. – Italy]

DR-XY27707

AERIUS Merck Sharp & Dohme

(I.A.) Corp. [Schering-

Plough Labo N.V. –

Belgium]

DR-XY39221

2.5 mg

Orodispersible

Tablet

AERIUS Merck Sharp & Dohme

(I.A.) Corp. [CIMA Labs.,

Inc. – USA]

DR-XY37393

5 mg

Orodispersible

Tablet

AERIUS Merck Sharp & Dohme

(I.A.) Corp. [CIMA Labs.,

Inc. – USA]

DR-XY37394

Desloratadine +

Pseudoephedrine

Sulfate

2.5mg/120mg

Extended-Release

Tablet

CLARINEX-D

12 HOUR

Merck Sharp & Dohme

Corp.3

Not available

locally

5mg/240mg

Extended-Release

Tablet

CLARINEX-D

24 HOUR

Merck Sharp & Dohme

Corp.3

Not available

locally

Desogestrel 75 mcg Tablet CERAZETTE Merck Sharp & Dohme

(I.A.) Corp. [N.V. Organon

– Netherlands]

DR-XY27146

Desogestrel +

Ethinylestradiol

150 mcg/20 mcg

Tablet

MERCILON Merck Sharp & Dohme

(I.A.) Corp. [Organon

Ireland Ltd. – Ireland]

DR-XY21633

150 mcg/30 mcg

Tablet

MARVELON 28 Merck Sharp & Dohme

(I.A.) Corp. [N.V. Organon

– Netherlands]

DR-XY2299

25 mcg/40 mcg

Tablet + 125

mcg/30 mcg

Tablet

GRACIAL Aspen Phils., Inc.

[Organon Ireland Ltd. –

Ireland]

DR-XY26961

Desvenlafaxine (as

Succinate)

25mg Extended-

Release Tablet

PRISTIQ Wyeth Pharmaceuticals

Inc.3

Not available

locally

50mg Extended-

Release Tablet

PRISTIQ SR Pfizer Inc. [Pfizer Ireland

Pharmaceuticals – Ireland]

DR-XY36221

100mg Extended-

Release Tablet

PRISTIQ Wyeth Pharmaceuticals

Inc.3

Not available

locally

Dexamethasone 500 mcg Tablet

ORADEXON Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-2540

DECILONE Westmont Pharm’ls, Inc.

[Asian Antibiotics, Inc.]

DR-6271

750 mcg Tablet DRENEX United American Pharm’ls,

Inc. [Asian Antibiotics,

Inc.]

DR-6722

Page 36:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

36

3 mg Tablet DRENEX United American Pharm’ls,

Inc. [Asian Antibiotics,

Inc.]

DR-7198

4 mg Tablet DECILONE

FORTE

Westmont Pharm’ls, Inc.

[Asian Antibiotics, Inc.]

DR-6518

Dexlansoprazole 30mg Delayed-

Release Capsule

DEXILANT Takeda Healthcare

Philippines, Inc. [Takeda

Pharmaceutical Co. Ltd. –

Japan]

DR-XY41455

60mg Delayed-

Release Capsule

DEXILANT Takeda Healthcare

Philippines, Inc. [Takeda

Pharmaceutical Co. Ltd. –

Japan]

DR-XY41456

30mg Orally-

Disintegrating

Tablet (Delayed-

Release)

DEXILANT

SOLUTAB

Takeda Pharmaceuticals

USA Inc.3

Not available

locally

Dexmethylphenidate

Hydrochloride

2.5mg Tablet FOCALIN Novartis Pharmaceuticals

Corp.3

Not available

locally

5mg Tablet FOCALIN Novartis Pharmaceuticals

Corp.3

Not available

locally

10mg Tablet FOCALIN Novartis Pharmaceuticals

Corp.3

Not available

locally

5mg Extended-

Release Capsule

FOCALIN XR Novartis Pharmaceuticals

Corp.3

Not available

locally

10mg Extended-

Release Capsule

FOCALIN XR Novartis Pharmaceuticals

Corp.3

Not available

locally

15mg Extended-

Release Capsule

FOCALIN XR Novartis Pharmaceuticals

Corp.3

Not available

locally

20mg Extended-

Release Capsule

FOCALIN XR Novartis Pharmaceuticals

Corp.3

Not available

locally

25mg Extended-

Release Capsule

FOCALIN XR Novartis Pharmaceuticals

Corp.3

Not available

locally

30mg Extended-

Release Capsule

FOCALIN XR Novartis Pharmaceuticals

Corp.3

Not available

locally

35mg Extended-

Release Capsule

FOCALIN XR Novartis Pharmaceuticals

Corp.3

Not available

locally

40mg Extended-

Release Capsule

FOCALIN XR Novartis Pharmaceuticals

Corp.3

Not available

locally

Diazepam 5mg Tablet VALIUM Roche (Philippines) Inc.

[Roche Farma SA – Spain]

DR-XY37749

10mg Tablet VALIUM Roche (Philippines) Inc.

[Roche Farma SA – Spain]

DR-XY37748

Diclofenac potassium

12.5 mg Tablet VOLTAREN

RAPID

Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY35520

Page 37:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

37

25 mg Tablet CATAFLAM Novartis Healthcare Phils.,

Inc. [Novartis Urunleri –

Turkey]

DRP-4018

50 mg Tablet CATAFLAM Novartis Healthcare Phils.,

Inc. [Novartis Urunleri –

Turkey]

DR-XY29124

Diclofenac sodium 25 mg Enteric-

Coated Tablet

VOLTAREN Novartis Healthcare Phils.,

Inc. [Novartis Urunleri –

Turkey]

DR-XY28428

50 mg Enteric-

Coated Tablet

VOLTAREN

FORTE

Novartis Healthcare Phils.,

Inc. [Novartis Urunleri –

Turkey]

DR-XY27769

100 mg Sustained-

Release Tablet

VOLTAREN SR Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Stein AG – Switzerland]

DR-XY27795

Dicycloverine

hydrochloride

10 mg Tablet BENTYL Sanofi-Aventis Phils., Inc.

[Sanofi-Synthelabo Ltd. –

United Kingdom]

DR-XY13526

20mg Tablet BENTYL Forest Laboratories, Inc.3 Not available

locally

Diethylcarbamazine

citrate

50 mg Tablet SUPATONIN Mitsubishi Tanabe Pharma

– Japan4

Not available

locally

50 mg Tablet

BANOCIDE GlaxoSmithKline Pharm’ls

Ltd. – India

Not available

locally

100 mg Tablet

BANOCIDE

FORTE

GlaxoSmithKline Pharm’ls

Ltd. – India

Not available

locally

Digoxin 62.5mcg Tablet LANOXIN Aspen2 Not available

locally Concordia Pharmaceuticals

Inc.3

125mcg Tablet LANOXIN Aspen2 Not available

locally Concordia Pharmaceuticals

Inc.3

187.5mcg Tablet LANOXIN Concordia Pharmaceuticals

Inc.3

Not available

locally

250mcg Tablet LANOXIN Aspen Phils. Inc. [Aspen

Bad Oldesloe GmbH –

Germany]

DR-263

DR-XY40880

DR-XY44676

Diloxanide (as

furoate)

500 mg Tablet FURAMIDE/

DILOXANIDE

Amdipharm UK Ltd.2 Not available

locally

DILFUR St. Martin Pharm’l Labs.,

Inc.

DRP-1127

(DR-XY33834)

125 mg/5 mL Oral

Suspension

DILFUR St. Martin Pharm’l Labs.,

Inc.

DRP-3697

Diltiazem

hydrochloride

30 mg Tablet DILZEM Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2100

(DR-XY12597)

60 mg Tablet DILZEM Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2010

(DR-XY12596)

Page 38:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

38

90 mg Tablet DILZEM SA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-2012

120mg Tablet CARDIZEM Valeant International

Barbados SRL3

Not available

locally

60mg Modified-

Release Tablet

TILDIEM Sanofi2 Not available

locally

90mg Prolonged-

Release Tablet

TILDIEM

RETARD

Sanofi2 Not available

locally

120 mg Sustained-

Release Tablet

DILZEM OD Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-2009

180 mg Sustained-

Release Tablet

DILZEM SR Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-2011

240mg Extended-

Release Tablet

CARDIZEM LA Valeant International

Barbados SRL3

Not available

locally

300mg Extended-

Release Tablet

CARDIZEM LA Valeant International

Barbados SRL3

Not available

locally

360mg Extended-

Release Tablet

CARDIZEM LA Valeant International

Barbados SRL3

Not available

locally

420mg Extended-

Release Tablet

CARDIZEM LA Valeant International

Barbados SRL3

Not available

locally

60mg Prolonged-

Release Capsule

DILZEM Cephalon (UK) Limited2 Not available

locally

90mg Prolonged-

Release Capsule

DILZEM Cephalon (UK) Limited2 Not available

locally

120mg Prolonged-

/Extended-Release

Capsule

SLOZEM Merck2 Not available

locally DILZEM Cephalon (UK) Limited2

CARDIZEM CD Valeant International

Barbados SRL3

TIAZAC Valeant Pharmaceuticals

North America LLC3

180mg Prolonged-

/Extended-Release

Capsule

SLOZEM Merck2 Not available

locally DILZEM Cephalon (UK) Limited2

CARDIZEM CD Valeant International

Barbados SRL3

TIAZAC Valeant Pharmaceuticals

North America LLC3

200mg Prolonged-

Release Capsule

TILDIEM LA Sanofi2 Not available

locally

SLOZEM Merck2 Not available

locally DILZEM Cephalon (UK) Limited2

Page 39:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

39

240mg Prolonged-

/Extended-Release

Capsule

CARDIZEM CD Valeant International

Barbados SRL3

TIAZAC Valeant Pharmaceuticals

North America LLC3

300mg Prolonged-

/Extended-Release

Capsule

SLOZEM Merck2 Not available

locally TILDIEM LA Sanofi2

CARDIZEM CD Valeant International

Barbados SRL3

TIAZAC Valeant Pharmaceuticals

North America LLC3

360mg Extended-

Release Capsule

CARDIZEM CD Valeant International

Barbados SRL3

Not available

locally

TIAZAC Valeant Pharmaceuticals

North America LLC3

420mg Extended-

Release Capsule

TIAZAC Valeant Pharmaceuticals

North America LLC3

Not available

locally

Dimethyl fumarate 120 mg Delayed-

Release Capsule

TECFIDERA Biogen Idec2, 3 Not available

locally

240 mg Delayed-

Release Capsule

TECFIDERA Biogen Idec2, 3 Not available

locally

Diosmin +

Hesperidin

450 mg/50 mg

Tablet

DAFLON 500 Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY12979

Diphenhydramine

Hydrochloride

25mg Capsule BENADRYL

AH

Johnson & Johnson

(Phils.), Inc. [Interphil

Laboratories, Inc.]

DR-4620

50mg Capsule BENADRYL

AH

Johnson & Johnson

(Phils.), Inc. [Interphil

Laboratories, Inc.]

DR-4621

Dipyridamole 25mg Tablet PERSANTIN Boehringer Ingelheim

Phils. Inc. [Interphil Labs.

Inc.]

DR-1746

50mg Tablet PERSANTINE Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

75mg Tablet PERSANTINE Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

100mg Tablet PERSANTIN Boehringer Ingelheim

Limited2

Not available

locally

200mg Modified-

Release Capsule

PERSANTIN

RETARD

Boehringer Ingelheim

Limited2

Not available

locally

Divalproex sodium

(equivalent to

Valproic Acid)

250 mg Extended-

Release Tablet

DEPAKOTE ER Abbott Labs. [AbbVie Ltd.

– Puerto Rico]

DR-XY30617

500 mg Extended-

Release Tablet

DEPAKOTE ER Abbott Labs. [AbbVie Ltd.

– Puerto Rico]

DR-XY29325

125 mg Capsule

(Sprinkle)

DEPAKOTE Abbott Labs. [Abbott Labs.

– USA]

DR-XY30637

Page 40:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

40

125mg Delayed-

Release Tablet

DEPAKOTE Abbvie Inc.3 Not available

locally

250 mg Enteric-

Coated Tablet

EPIVAL Abbott Labs. [PT. Abbott

Indonesia – Indonesia]

DR-XY34509

500mg Delayed-

Release Tablet

DEPAKOTE Abbvie Inc.3 Not available

locally

Dolutegravir (as

sodium)

10mg Tablet TIVICAY ViiV Healthcare UK Ltd.2 Not available

locally ViiV Healthcare Co.3

25mg Tablet TIVICAY ViiV Healthcare UK Ltd.2 Not available

locally ViiV Healthcare Co.3

50mg Tablet TIVICAY ViiV Healthcare UK Ltd.2 Not available

locally ViiV Healthcare Co.3

Domperidone 10 mg Tablet MOTILIUM Johnson & Johnson

(Phils.), Inc. [Interphil

Laboratories, Inc.]

DR-XY25762

MOTILIUM-M Johnson & Johnson

(Phils.), Inc. [Janssen

Korea Ltd. – Korea]

DR-XY40069

1 mg/mL

(5 mg/5 mL)

Oral Suspension

MOTILIUM Johnson & Johnson

(Phils.), Inc. [Janssen

Pharmaceutica – Belgium]

DR-X8545

Donepezil

hydrochloride

5 mg Tablet

ARICEPT HI-Eisai Pharm’l, Inc.

[Bora Pharmaceuticals Co.,

Ltd – China]

DR-XY33832

10 mg Tablet

ARICEPT HI-Eisai Pharm’l, Inc.

[Bora Pharmaceuticals Co.,

Ltd – China]

DR-XY33828

23 mg Tablet ARICEPT HI-Eisai Pharm’l, Inc.

[Bora Pharmaceuticals Co.

– China]

DR-XY42383

5 mg

Orodispersible

Tablet

ARICEPT

EVESS

HI-Eisai Pharm’l, Inc.

[Eisai Co., Ltd./Bushu

Pharm’ls Ltd. – Japan]

DR-XY35549

10 mg

Orodispersible

Tablet

ARICEPT

EVESS

HI-Eisai Pharm’l, Inc.

[Eisai Co., Ltd./Bushu

Pharm’ls Ltd. – Japan]

DR-XY35548

Donepezil

hydrochloride +

Memantine

Hydrochloride

10mg/7mg

Extended-Release

Capsule

NAMZARIC Forest Laboratories LLC3 Not available

locally

10mg/14mg

Extended-Release

Capsule

NAMZARIC Forest Laboratories LLC3 Not available

locally

10mg/21mg

Extended-Release

Capsule

NAMZARIC Forest Laboratories LLC3 Not available

locally

Page 41:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

41

10mg/28mg

Extended-Release

Capsule

NAMZARIC Forest Laboratories LLC3 Not available

locally

Doxofylline 200mg Tablet ANSIMAR OEP Philippines, Inc.

[Hizon Labs., Inc.]

DR-XY35373

400mg Tablet ANSIMAR OEP Philippines, Inc.

[ABC Farmaceutici S.P.A.

– Italy]

DRP-7009

(DR-XY31381)

Doxycycline (as

calcium)

50mg/5mL Oral

Suspension

VIBRAMYCIN Pfizer Laboratories Div

Pfizer Inc.3

Not available

locally

Doxycycline (as

hyclate).

75mg Capsule ACTICLATE

CAP

Aqua Pharmaceuticals3 Not available

locally

100 mg Capsule VIBRAMYCIN Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-2077

75mg Tablet ACTICLATE Aqua Pharmaceuticals3 Not available

locally

150mg Tablet ACTICLATE Aqua Pharmaceuticals3 Not available

locally

50mg Delayed-

Release Tablet

DORYX Mayne Pharma

International Pty Ltd.3

Not available

locally

60mg Delayed-

Release Tablet

DORYX MPC Mayne Pharma

International Pty Ltd.3

Not available

locally

75mg Delayed-

Release Tablet

DORYX Mayne Pharma

International Pty Ltd.3

Not available

locally

80mg Delayed-

Release Tablet

DORYX Mayne Pharma

International Pty Ltd.3

Not available

locally

100mg Delayed-

Release Tablet

DORYX Mayne Pharma

International Pty Ltd.3

Not available

locally

120mg Delayed-

Release Tablet

DORYX MPC Mayne Pharma

International Pty Ltd.3

Not available

locally

150mg Delayed-

Release Tablet

DORYX Mayne Pharma

International Pty Ltd.3

Not available

locally

200mg Delayed-

Release Tablet

DORYX Mayne Pharma

International Pty Ltd.3

Not available

locally

Doxycycline (as

monohydrate)

25mg/5mL

Powder for Oral

Suspension

VIBRAMYCIN Pfizer Laboratories Div

Pfizer Inc.3

Not available

locally

40mg Capsule ORACEA Galderma Laboratories LP3 Not available

locally

50mg Capsule MONODOX Aqua Pharmaceuticals3 Not available

locally

75mg Capsule MONODOX Aqua Pharmaceuticals3 Not available

locally

100mg Capsule MONODOX Aqua Pharmaceuticals3 Not available

locally

Page 42:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

42

100mg Dispersible

Tablet

VIBRAMYCIN-

D

Pfizer Limited2 Not available

locally

Doxylamine

succinate

25mg Tablet UNISOM Chattem Inc.3 Not available

locally

Doxylamine

succinate +

Pyridoxine

hydrochloride

10mg/10mg

Delayed-Release

Tablet

DICLEGIS Duchesnay Inc.3 Not available

locally

20mg/20mg

Extended-Release

Tablet

BONJESTA Duchesnay Inc.3 Not available

locally

Drospirenone +

Ethinylestradiol

3 mg/30 mcg

Tablet

YASMIN Bayer Phils., Inc. [Bayer

Weimar GmbH und Co.

KG – Germany]

DR-XY28181

3 mg/20 mcg YAZ Bayer Phils., Inc. [Bayer

Weimar GmbH und Co.

KG – Germany]

DR-XY34970

Drospirenone +

Estradiol (as

hemihydrate)

250mcg/500mg

Tablet

ANGELIQ Bayer Healthcare

Pharmaceuticals Inc.3

Not available

locally

500mcg/1mg

Tablet

ANGELIQ Bayer Healthcare

Pharmaceuticals Inc.3

Not available

locally

2mg/1mg Tablet ANGELIQ Bayer plc2 Not available

locally

Duloxetine

hydrochloride

20mg Delayed-

Release Capsule

CYMBALTA Eli Lilly and Co.3 Not available

locally

30 mg Delayed-

Release Capsule

CYMBALTA Eli Lilly (Phils.), Inc. [Lilly

del Caribe, Inc. – Puerto

Rico]

DR-XY31173

CYMBALTA Eli Lilly (Phils.), Inc. [Lilly

del Caribe, Inc. – Puerto

Rico]

DR-XY31175

60 mg Delayed-

Release Capsule

CYMBALTA Eli Lilly (Phils.), Inc. [Lilly

del Caribe, Inc. – Puerto

Rico]

DR-XY41867

Dutasteride 500 mcg Capsule AVODART GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Pharm’ls S.A. – Poland]

DR-XY29399

Dydrogesterone 10 mg Tablet DUPHASTON Abbott Labs. [Abbott

Biologicals B.V. –

Netherlands]

DRP-221

Efavirenz 50mg Capsule SUSTIVA Bristol-Myers Squibb

Pharmaceutical Limited2

Not available

locally

Bristol-Myers Squibb3

100mg Capsule SUSTIVA Bristol-Myers Squibb

Pharmaceutical Limited2

Not available

locally

200mg Capsule SUSTIVA Bristol-Myers Squibb

Pharmaceutical Limited2

Not available

locally

Bristol-Myers Squibb3

Page 43:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

43

600mg Tablet SUSTIVA Bristol-Myers Squibb

Pharmaceutical Limited2

Not available

locally

Bristol-Myers Squibb3

Efavirenz +

Emtricitabine +

Tenofovir Disoproxil

Fumarate

600mg/200mg/300

mg Tablet

ATRIPLA Gilead Sciences Ltd.2 Not available

locally

Gilead Sciences Inc.3

Efavirenz +

Lamivudine +

Tenofovir Disoproxil

Fumarate

400mg/300mg/300

mg Tablet

SYMFI LO Mylan Pharmaceuticals

Inc.3

Not available

locally

600mg/300mg/300

mg Tablet

SYMFI Mylan Laboratories Ltd.3 Not available

locally

Eletriptan (as

Hydrobromide)

20mg Tablet RELPAX Pfizer Inc. [Pfizer

Manufacturing

Deutschland – Germany]

DR-XY41148

40mg Tablet RELPAX Pfizer Inc. [Pfizer

Manufacturing

Deutschland – Germany]

DR-XY41201

Eltrombopag (as

Olamine)

12.5mg Tablet PROMACTA Novartis Pharmaceuticals

Corp.3

Not available

locally

25mg Tablet REVOLADE GlaxoSmithKline

Philippines, Inc. [Glaxo

Wellcome Operation –

UK]

DR-XY39364

50mg Tablet REVOLADE GlaxoSmithKline

Philippines, Inc. [Glaxo

Wellcome Operation –

UK]

DR-XY39363

75mg Tablet REVOLADE Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

PROMACTA Novartis Pharmaceuticals

Corp.3

100mg Tablet PROMACTA Novartis Pharmaceuticals

Corp.3

Not available

locally

25mg Powder for

Oral Suspension

PROMACTA Novartis Pharmaceuticals

Corp.3

Not available

locally

Elvitegravir +

Cobicistat +

Emtricitabine +

Tenofovir

Alafenamide (as

Fumarate)

150mg/150mg/

200mg/10mg

Tablet

GENVOYA Gilead Sciences Ltd.2 Not available

locally

Gilead Sciences Inc.3

Elvitegravir +

Cobicistat +

Emtricitabine +

Tenofovir Disoproxil

Fumarate

150mg/150mg/

200mg/300mg

Tablet

STRIBILD Gilead Sciences Ltd.2 Not available

locally

Gilead Sciences Inc.3

Page 44:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

44

Empagliflozin 10 mg Tablet JARDIANCE Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY44690

25 mg Tablet JARDIANCE Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY44689

Empagliflozin +

Linagliptin

10mg/5mg Tablet GLYXAMBI Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45734

25mg/5mg Tablet GLYXAMBI Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45733

Empagliflozin +

Metformin

Hydrochloride

5mg/500mg Tablet JARDIANCE

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45442

5mg/850mg Tablet JARDIANCE

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45443

5mg/1g Tablet JARDIANCE

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45444

12.5mg/500mg

Tablet

JARDIANCE

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45445

12.5mg/850mg

Tablet

JARDIANCE

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45446

12.5mg/1mg

Tablet

JARDIANCE

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45447

5mg/1mg

Extended-Release

Tablet

SYNJARDY XR Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

10mg/1mg

Extended-Release

Tablet

SYNJARDY XR Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

Page 45:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

45

12.5mg/1mg

Extended-Release

Tablet

SYNJARDY XR Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

25mg/1mg

Extended-Release

Tablet

SYNJARDY XR Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

Emtricitabine 200mg Capsule EMTRIVA Gilead Sciences Ltd.2 Not available

locally Gilead Sciences Inc.3

Emtricitabine +

Rilpivirine (as

Hydrochloride) +

Tenofovir

Alafenamide (as

Fumarate)

200mg/25mg/25m

g Tablet

ODEFSEY Gilead Sciences Ltd.2 Not available

locally

Gilead Sciences Inc.3

Emtricitabine +

Rilpivirine (as

Hydrochloride) +

Tenofovir Disoproxil

Fumarate

200mg/25mg/

300mg Tablet

EVIPLERA Gilead Sciences Ltd.2 Not available

locally

COMPLERA Gilead Sciences Inc.3

Emtricitabine +

Tenofovir

Alafenamide (as

Fumarate)

200mg/10mg

Tablet

DESCOVY Gilead Sciences Ltd.2 Not available

locally

200mg/25mg

Tablet

DESCOVY Gilead Sciences Ltd.2 Not available

locally Gilead Sciences Inc.3

Emtricitabine +

Tenofovir Disoproxil

Fumarate

100mg/150mg

Tablet

TRUVADA Gilead Sciences Inc.3 Not available

locally

133mg/200mg

Tablet

TRUVADA Gilead Sciences Inc.3 Not available

locally

167mg/250mg

Tablet

TRUVADA Gilead Sciences Inc.3 Not available

locally

200mg/300mg

Tablet

TRUVADA LF (Philippines), Inc.

[Takeda GmbH –

Germany]

DR-XY44050

Enalapril maleate 2.5mg Tablet INNOVACE Merck Sharp & Dohme

Limited2

Not available

locally

VASOTEC Valeant Pharmaceuticals

North America LLC3

5 mg Tablet RENITEC Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-4590

(DR-XY3886)

10 mg Tablet RENITEC Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-4890

(DR-XY4212)

20 mg Tablet RENITEC Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

DRP-4579

(DR-XY3885)

Page 46:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

46

& Dohme Ltd. – United

Kingdom]

Enalapril Maleate +

Hydrochlorothiazide

5mg/12.5mg

Tablet

VASERETIC Valeant International

Barbados Srl3

Not available

locally

10mg/25mg Tablet VASERETIC Valeant International

Barbados Srl3

Not available

locally

20 mg/12.5 mg

Tablet

CO-RENITEC Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-6240

(DR-XY16700)

Entacapone 200mg Tablet COMTAN Novartis Healthcare

Philippines, Inc. [Orion

Corporation – Finland]

DR-XY26208

Entecavir 500 mcg Tablet BARACLUDE Zuellig Pharma Corp.

[Bristol-Myers Squibb Co.

– USA]

DR-XY31277

1 mg Tablet BARACLUDE Zuellig Pharma Corp.

[Bristol-Myers Squibb Co.

– USA]

DR-XY31276

Enzalutamide 40mg Capsule XTANDI Astellas Pharma

Philippines, Inc. [Catalent

Pharma Solutions LLC –

USA]

DR-XY44002

Eperisone

hydrochloride

50 mg Tablet MYONAL HI-Eisai Pharm’l, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY22030

Eplerenone 25mg Tablet INSPRA Pfizer, Inc. [Pfizer

Pharmaceuticals LLC –

USA]

DR-XY30974

50mg Tablet INSPRA Pfizer, Inc. [Pfizer

Pharmaceuticals LLC –

USA]

DR-XY30975

Eprosartan (as

Mesilate)

300mg Tablet TEVETEN Mylan Products Limited2 Not available

locally

400mg Tablet TEVETEN Mylan Pharmaceuticals

Inc,3

Not available

locally

600mg Tablet TEVETEN Abbott Products Phils. Inc.

[Abbott Healthcare SAS –

France]

DRP-301

Erdosteine 300mg Capsule ZERTIN GlaxoSmithKline

Philippines, Inc. [Famar

Italia S.p.A. – Italy]

DR-XY30847

ECTRIN OEP Philippines, Inc.

[Hizon Laboratories, Inc.]

DR-XY29596

175mg/5mL

Powder for

Suspension

ZERTIN GlaxoSmithKline

Philippines, Inc. [Hizon

Laboratories, Inc.]

DR-XY32205

Page 47:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

47

ECTRIN OEP Philippines, Inc.

[Hizon Laboratories, Inc.]

DR-XY30165

Erlotinib (as

hydrochloride)

25 mg Tablet TARCEVA Roche (Phils.), Inc.

[Kremers Urban Pharm’ls,

Inc. – USA]

DR-XY31270

TARCEVA Roche (Phils.), Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY36901

100 mg Tablet TARCEVA Roche (Phils.), Inc.

[Kremers Urban Pharm’ls,

Inc. – USA]

DR-XY31271

TARCEVA Roche (Phils.), Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY36900

TARCEVA Roche (Phils.), Inc. [Roche

S.p.A. – Italy]

DR-XY40838

150 mg Tablet TARCEVA Roche (Phils.), Inc.

[Kremers Urban Pharm’ls,

Inc. – USA]

DR-XY31269

TARCEVA Roche (Phils.), Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY35967

TARCEVA Roche (Phils.), Inc. [Roche

S.p.A. – Italy]

DR-XY40837

Erythromycin

estolate

100 mg/mL Oral

Suspension

ILOSONE Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-1773

125 mg/5 mL Oral

Suspension

ILOSONE Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-1779

250 mg/5 mL Oral

Suspension

ILOSONE DS Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-XY10241-

L

Erythromycin

ethylsuccinate

200 mg/5 mL

Powder or

Granules for Oral

Suspension

ERYTHROCIN A. Menarini Phils., Inc.

[Interphil Labs., Inc.]

DR-785

EPERTOCYN Eadriex Pharm’ls Phils.,

Inc. [Lloyd Laboratories,

Inc.]

DRP-2237

(DR-XY12272)

Unbranded Pharex Health Corp.

[Pascual Labs., Inc.]

DR-XY16473

400 mg/5 mL

Powder or

Granules for Oral

Suspension

ERYTHROCIN

DS

A. Menarini Phils., Inc.

[Interphil Labs., Inc.]

DR-XY3293

ROMAXIN ProHealth Pharma Phils.,

Inc. [Lloyd Laboratories,

Inc.]

DR-XY13605

Erythromycin

stearate

250 mg Tablet ERYTHROCIN A. Menarini Phils., Inc.

[Interphil Labs., Inc.]

DR-XY15612

ETRIOGAPE Pascual Labs., Inc.

[Pascual Labs., Inc.]

DR-XY16271-

B

Page 48:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

48

Unbranded Pharex Health Corp.

[Pascual Labs., Inc.]

DR-XY16271

500 mg Tablet ERYTHROCIN A. Menarini Phils., Inc.

[Interphil Labs., Inc.]

DR-X585

ETRIOGAPE Pascual Labs., Inc.

[Pascual Labs., Inc.]

DR-XY16566-

B

Unbranded Pharex Health Corp.

[Pascual Labs., Inc.]

DR-XY16566

Escitalopram (as

oxalate)

5 mg Tablet LEXAPRO Metro Drug, Inc. [H.

Lunbeck A/S – Denmark]

DR-XY29577

10 mg Tablet LEXAPRO Metro Drug, Inc. [H.

Lunbeck A/S – Denmark]

DR-XY29575

15 mg Tablet LEXAPRO Metro Drug, Inc. [H.

Lunbeck A/S – Denmark]

DR-XY29576

20 mg Tablet LEXAPRO Metro Drug, Inc. [H.

Lunbeck A/S – Denmark]

DR-XY29578

Eslicarbazepine

Acetate

200mg Tablet ZEBINIX Eisai Ltd.2 Not available

locally APTIOM Sunovion Pharmaceuticals

Inc.3

400mg Tablet APTIOM Sunovion Pharmaceuticals

Inc.3

Not available

locally

600mg Tablet APTIOM Sunovion Pharmaceuticals

Inc.3

Not available

locally

800mg Tablet ZEBINIX Eisai Ltd.2 Not available

locally APTIOM Sunovion Pharmaceuticals

Inc.3

Esomeprazole (as

magnesium

trihydrate)

2.5mg Granules

for Oral

Suspension

NEXIUM Astrazeneca

Pharmaceuticals LP3

Not available

locally

5mg Granules for

Oral Suspension

NEXIUM Astrazeneca

Pharmaceuticals LP3

Not available

locally

10 mg Granules

for Oral

Suspension

NEXIUM AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

AB – Sweden]

DR-XY35546

20mg Granules for

Oral Suspension

NEXIUM Astrazeneca

Pharmaceuticals LP3

Not available

locally

40mg Granules for

Oral Suspension

NEXIUM Astrazeneca

Pharmaceuticals LP3

Not available

locally

20 mg Enteric-

coated Tablet

NEXIUM AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

AB – Sweden]

DR-XY27082

40 mg Enteric-

coated Tablet

NEXIUM AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

AB – Sweden]

DR-XY27081

20mg Delayed-

Release Capsule

NEXIUM Astrazeneca

Pharmaceuticals LP3

Not available

locally

Page 49:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

49

40mg Delayed-

Release Capsule

NEXIUM Astrazeneca

Pharmaceuticals LP3

Not available

locally

Esomeprazole (as

strontium)

20mg (equivalent

to 24.65mg

Esomeprazole

Strontium)

Delayed-Release

Capsule

ESOMEPRAZO

LE

STRONTIUM

R2 Pharma LLC3 Not available

locally

40mg (equivalent

to 49.3mg

Esomeprazole

Strontium)

Delayed-Release

Capsule

ESOMEPRAZO

LE

STRONTIUM

R2 Pharma LLC3 Not available

locally

Esomeprazole (as

magnesium

trihydrate) +

Naproxen

20mg/375mg

Delayed-Release

Tablet

VIMOVO Horizon Pharma USA Inc.3 Not available

locally

20mg/500mg

Delayed-Release

Tablet

VIMOVO AstraZeneca

Pharmaceuticals (Phils.),

Inc. [Patheon Pharm’l. Inc.

– USA]

DR-XY39259

Estramustine

phosphate (as

sodium)

140 mg Capsule ESTRACYT Pfizer Limited2 Not available

locally EMCYT Pharma and Upjohn3

Ethambutol 100 mg Tablet MYAMBUTOL STI Pharma LLC3 Not available

locally

400 mg Tablet MYAMBUTOL Riemser Arzneimittel AG

or Teofarma S.r.l.2

Not available

locally MYAMBUTOL STI Pharma LLC3 Not available

locally

Etoricoxib 30 mg Tablet ARCOXIA Merck Sharp & Dohme

(I.A.) Corp. [Frosst Iberica

S.A. – Spain]

DRP-4079

60 mg Tablet ARCOXIA Merck Sharp & Dohme

(I.A.) Corp. [Frosst Iberica

S.A. – Spain]

DRP-4080

90 mg Tablet ARCOXIA Merck Sharp & Dohme

(I.A.) Corp. [Frosst Iberica

S.A. – Spain]

DRP-3437

120 mg Tablet ARCOXIA AC Merck Sharp & Dohme

(I.A.) Corp. [Frosst Iberica

S.A. – Spain]

DRP-4081

Everolimus 250mcg Tablet CERTICAN Novartis Healthcare

Philippines, Inc. [Novartis

Pharma AG – Switzerland]

DR-XY34729

500mcg Tablet CERTICAN Novartis Healthcare

Philippines, Inc. [Novartis

DR-XY32448

Page 50:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

50

Pharma Stein AG –

Switzerland]

750mcg Tablet CERTICAN Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY32447

2.5mg Tablet AFINITOR Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY41780

5mg Tablet AFINITOR Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY39219

7.5mg Tablet AFINITOR Novartis Pharmaceuticals

Corp.3

Not available

locally

10mg Tablet AFINITOR Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY38276

2mg Dispersible

Tablet

AFINITOR Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY45143

3mg Dispersible

Tablet

AFINITOR Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY45144

5mg Dispersible

Tablet

AFINITOR Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY45145

Exemestane 25mg Tablet AROMASIN Pfizer Inc. [Pfizer Italia

S.r.l. – Italy]

DRP-1930

Ezetimibe 10 mg Tablet EZETROL Merck Sharp & Dohme

(I.A.) Corp. [Schering-

Plough Products Ltd. –

USA]

DRP-6251

(DR-XY28718)

Ezetimibe +

Simvastatin

10mg/10mg Tablet VYTORIN Merck Sharp & Dohme

(I.A.) Corp. [MSD Int’l

GmbH (Singapore

Branch)]

DRP-6253

10mg/20mg Tablet VYTORIN Merck Sharp & Dohme

(I.A.) Corp. [MSD Int’l

GmbH (Singapore

Branch)]

DRP-6252

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51

10mg/40mg Tablet VYTORIN Merck Sharp & Dohme

(I.A.) Corp. [MSD Int’l

GmbH (Singapore

Branch)]

DRP-6254

10mg/80mg Tablet INEGY Merck Sharp & Dohme

Limited2

Not available

locally

VYTORIN MSD International GmbH3

Famotidine 10mg Tablet PEPCID AC Johnson and Johnson

Consumer Inc. McNeil

Consumer Healthcare

Division3

Not available

locally

20mg Tablet PEPCID AC Johnson and Johnson

Consumer Inc. McNeil

Consumer Healthcare

Division3

Not available

locally

PEPCID Valeant Pharmaceuticals

North America LLC3

40mg Tablet PEPCID Valeant Pharmaceuticals

North America LLC3

Not available

locally

20mg Chewable

Tablet

PEPCID AC Johnson and Johnson

Consumer Inc. McNeil

Consumer Healthcare

Division3

Not available

locally

40mg/5mL

Powder for Oral

Suspension

PEPCID Salix Pharmaceuticals Inc.3 Not available

locally

Febuxostat 10 mg Tablet FEBURIC Teijin Pharma Ltd.4 Not available

locally

20 mg Tablet FEBURIC Teijin Pharma Ltd.4 Not available

locally

40 mg Tablet ULORIC Takeda Pharm’ls USA

Inc.3

Not available

locally

FEBURIC Teijin Pharma Ltd.4

80 mg Tablet FEBURIC Astellas Pharma

Philippines, Inc. [Patheon

France – France]

DR-XY45653

ADENURIC Menarini Int’l Operations

Luxembourg S.A.2

Not available

locally

ULORIC Takeda Pharm’ls USA

Inc.3

120 mg Tablet ADENURIC Menarini Int’l Operations

Luxembourg S.A.2

Not available

locally

Felodipine 2.5 mg Extended-

release Tablet

PLENDIL ER AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co. Ltd. – China]

DR-XY24163

Page 52:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

52

5 mg Extended-

release Tablet

PLENDIL ER AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co. Ltd. – China]

DR-XY16801

10 mg Extended-

release Tablet

PLENDIL ER AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co. Ltd. – China]

DR-XY16802

Immediate-Release

Tablet

The comparator product for Felodipine in immediate-release

tablet is not available locally. This should be purchased from a

well regulated market with a stringent regulatory authority

(SRA).

Felodipine +

Metoprolol succinate

5 mg/50 mg

Extended-Release

Tablet

LOGIMAX AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

AB – Sweden]

DR-XY23079

Felodipine +

Ramipril

2.5mg/2.5mg

Prolonged-Release

Tablet

TRIAPIN Sanofi-Aventis Philippines

[AstraZeneca – Sweden]

DR-XY29351

5mg/5mg

Prolonged-Release

Tablet

TRIAPIN Sanofi-Aventis Philippines

[AstraZeneca – Sweden]

DR-XY29407

Fenofibrate 30mg Micronized

Capsule

ANTARA

(MICRONIZED)

Lupin Atlantis Holdings

SA3

Not available

locally

43mg Micronized

Capsule

ANTARA

(MICRONIZED)

Lupin Atlantis Holdings

SA3

Not available

locally

67mg Micronized

Capsule

LIPANTHYL Abbott Products Phils., Inc.

[Recipharm Fontaine –

France]

DR-XY26190

90mg Micronized

Capsule

ANTARA

(MICRONIZED)

Lupin Atlantis Holdings

SA3

Not available

locally

130mg Micronized

Capsule

ANTARA

(MICRONIZED)

Lupin Atlantis Holdings

SA3

Not available

locally

200mg Micronized

Capsule

FIBRAFEN

200M

Abbott Laboratories

[Recipharm Fontaine –

France]

DRP-125

267mg Micronized

Capsule

LIPANTIL

MICRO 267

Mylan Products Limited2 Not available

locally

40mg Tablet FENOGLIDE Santarus Inc.3 Not available

locally

48mg Tablet TRICOR Abbvie Inc.3 Not available

locally

120mg Tablet FENOGLIDE Santarus Inc.3 Not available

locally

145 mg Tablet LIPANTHYL

NT

Abbott Products Phils., Inc.

[Fournier Labs. Ireland

Ltd. – Ireland]

DR-XY33285

160 mg Tablet LIPANTHYL

SUPRA

Abbott Products Phils., Inc.

[Recipharm Fontaine –

France]

DRP-122

Page 53:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

53

50mg Capsule LIPOFEN Cipher Pharmaceuticals

Inc.3

Not available

locally

150mg Capsule LIPOFEN Cipher Pharmaceuticals

Inc.3

Not available

locally

300 mg Capsule Either one of the abovementioned products should be used as

comparator drug in the conduct of in vivo bioequivalence

studies.

Fenofibric Acid (as

Choline Fenofibrate)

45mg Delayed-

Release Capsule

TRILIPIX Abbvie Inc.3 Not available

locally

135mg Delayed-

Release Capsule

TRILIPIX Abbvie Inc.3 Not available

locally

Fesoterodine

Fumarate

4mg Extended-

Release Tablet

TOVIAZ Pfizer Limited2 Not available

locally Pfizer Inc.3

8mg Extended-

Release Tablet

TOVIAZ Pfizer Limited2 Not available

locally Pfizer Inc.3

Fexofenadine

hydrochloride

30mg Tablet TELFAST Sanofi2 Not available

locally

CHILDREN’S

ALLEGRA

ALLERGY

Sanofi Aventis US LLC3

CHILDREN’S

ALLEGRA

HIVES

Sanofi Aventis US LLC3

60mg Tablet CHILDREN’S

ALLEGRA

ALLERGY

Sanofi Aventis US LLC3 Not available

locally

CHILDREN’S

ALLEGRA

HIVES

Sanofi Aventis US LLC3

120 mg Tablet TELFAST Sanofi-Aventis Philippines,

Inc. [PT. Aventis Pharma –

Indonesia]

DRP-2109

180 mg Tablet TELFAST Sanofi-Aventis Philippines,

Inc. [PT. Aventis Pharma –

Indonesia]

DRP-2108

30mg Orally

Disintegrating

Tablet

CHILDREN’S

ALLEGRA

ALLERGY

Sanofi Aventis US LLC3 Not available

locally

CHILDREN’S

ALLEGRA

HIVES

Sanofi Aventis US LLC3

30mg/5mL Oral

Suspension

ALLEGRA Sanofi Aventis US LLC3 Not available

locally CHILDREN’S

ALLEGRA

ALLERGY

Sanofi Aventis US LLC3

Page 54:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

54

CHILDREN’S

ALLEGRA

HIVES

Sanofi Aventis US LLC3

Fexofenadine

hydrochloride +

Pseudoephedrine

Hydrochloride

60mg/120mg

Extended-Release

Tablet

ALLEGRA-D 12

HOUR

ALLERGY

AND

CONGESTION

Sanofi Aventis US LLC3 Not available

locally

180mg/240mg

Extended-Release

Tablet

ALLEGRA-D 24

HOUR

ALLERGY

AND

CONGESTION

Sanofi Aventis US LLC3 Not available

locally

Finasteride 1 mg Tablet PROPECIA Merck Sharp & Dohme

(I.A.) Corp. [MSD Int’l

GmbH LLC – Puerto Rico]

DR-XY25359

5 mg Tablet PROSCAR Merck Sharp & Dohme

(I.A.) Corp. [MSD Int’l

GmbH LLC/AIAC

International Pharma LLC

– Puerto Rico]

DR-XY16541

Fingolimod (as

Hydrochloride)

500mg Capsule GILENYA Novartis Healthcare

Philippines Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY42890

Flecainide acetate

50mg Tablet TAMBOCOR Meda Pharmaceuticals2 Not available

locally County Line

Pharmaceuticals LLC3

100 mg Tablet TAMBOCOR Metro Drug, Inc. [3M

Healthcare Ltd. – United

Kingdom]

DR-XY3966

150mg Tablet TAMBOCOR County Line

Pharmaceuticals LLC3

Not available

locally

100 mg Modified-

Release Capsule

TAMBOCOR

CR

Metro Drug, Inc. [3M

Healthcare Ltd. – United

Kingdom]

DR-XY37105

200 mg Modified-

Release Capsule

TAMBOCOR

CR

Metro Drug, Inc. [3M

Healthcare Ltd. – United

Kingdom]

DR-XY37106

Flucloxacillin (as

sodium)

250 mg Capsule FLOXAPEN Actavis UK Ltd.2 Not available

locally

STAFLOXIN Westmont Pharm’ls, Inc.

[Asian Antibiotics, Inc.]

DR-XY16012

500 mg Capsule FLOXAPEN Actavis UK Ltd.2 Not available

locally

STAFLOXIN Westmont Pharm’ls, Inc.

[Asian Antibiotics, Inc.]

DR-XY16013

Page 55:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

55

Flucloxacillin (as

magnesium)

125 mg/5 mL

Powder or

Granules for Oral

Suspension

STAFLOXIN Westmont Pharm’ls, Inc.

[Asian Antibiotics, Inc.]

DR-XY26295

Fluconazole 50 mg Capsule DIFLUCAN Pfizer, Inc. [Pfizer Pty.

Ltd. – Australia]

DRP-1965

100mg Capsule DIFLUCAN Pfizer Central Research3 Not available

locally

150 mg Capsule DIFLUCAN Pfizer, Inc. [Pfizer Pty.

Ltd. – Australia]

DRP-1964

200 mg Capsule DIFLUCAN Pfizer, Inc. [Pfizer Pty.

Ltd. – Australia]

DRP-1963

10mg/mL

(50mg/5mL)

Powder for Oral

Suspension

DIFLUCAN Pfizer Limited2 Not available

locally Pfizer Chemicals Div

Pfizer Inc.3

40mg/mL

(200mg/5mL)

Powder for Oral

Suspension

DIFLUCAN Pfizer Limited2 Not available

locally Pfizer Chemicals Div

Pfizer Inc.3

Fludarabine

Phosphate

10mg Tablet FLUDARA Sanofi-Aventis Philippines

Inc. [Bayer Pharma AG –

Germany]

DR-XY29164

Flunarizine (as

hydrochloride)

5 mg Capsule SIBELIUM Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

S.p.A. – Italy]

DR-XY29450

SIBELIUM Johnson & Johnson

(Phils.), Inc. [Janssen

Korea Ltd. – Korea]

DR-XY38084

Fluoxetine (as

hydrochloride)

10mg Capsule PROZAC Eli Lilly and Co.3 Not available

locally

20 mg Capsule PROZAC Eli Lilly (Philippines), Inc.

[Patheon France – France]

DR-XY13199

40mg Capsule PROZAC Eli Lilly and Co.3 Not available

locally

90mg Delayed-

Release Capsule

PROZAC

WEEKLY

Eli Lilly and Co.3 Not available

locally

10mg Tablet SARAFEM Allergan Pharmaceuticals

International Ltd.3

Not available

locally

15mg Tablet SARAFEM Allergan Pharmaceuticals

International Ltd.3

Not available

locally

20mg Tablet SARAFEM Allergan Pharmaceuticals

International Ltd.3

Not available

locally

60mg Tablet Unbranded Alvogen Group Holdings 3

LLC3

Not available

locally

25mg/3mg

Capsule

SYMBYAX Eli Lilly and Co.3 Not available

locally

Page 56:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

56

Fluoxetine (as

Hydrochloride) +

Olanzapine

25mg/6mg

Capsule

SYMBYAX Eli Lilly and Co.3 Not available

locally

25mg/12mg

Capsule

SYMBYAX Eli Lilly and Co.3 Not available

locally

50mg/6mg

Capsule

SYMBYAX Eli Lilly and Co.3 Not available

locally

50mg/12mg

Capsule

SYMBYAX Eli Lilly and Co.3 Not available

locally

Fluvastatin (as

Sodium)

20mg Capsule LESCOL Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

40mg Capsule LESCOL Novartis Healthcare

Philippines Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY18559

80mg Extended-

Release Tablet

LESCOL XL Novartis Healthcare

Philippines Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY27044

Fluvoxamine Maleate 50mg Tablet FAVERIN Solvay/Mylan Products

Limited2

Not available

locally

100mg Tablet FAVERIN Solvay/Mylan Products

Limited2

Not available

locally

Fosinopril sodium 10 mg Tablet BP NORM Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY37250

20 mg Tablet BP NORM Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY37046

Furazolidone 100mg Tablet FUROXONE2,3 Not available

locally

50mg/15mL Oral

Suspension

FUROXONE2,3 Not available

locally

Furosemide 20 mg Tablet LASIX US Pharmaceutical

Holdings II LLC3

Not available

locally

FRUSEMA L.R. Imperial, Inc.

[Amherst Labs., Inc.]

DR-X887

40 mg Tablet LASIX Sanofi-Aventis Phils., Inc.

[Handok Pharm’l Co. Ltd.

– Korea]

DR-1110

FRUSEMA L.R. Imperial, Inc.

[Amherst Labs., Inc.]

DR-X886

80mg Tablet LASIX US Pharmaceutical

Holdings II LLC3

Not available

locally

Gabapentin 100 mg Capsule NEURONTIN Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-1993

300 mg Capsule NEURONTIN Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-1967

Page 57:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

57

400 mg Capsule NEURONTIN Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-1988

600 mg Tablet NEURONTIN Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-3447

800mg Tablet NEURONTIN Pfizer Limited2 Not available

locally Pfizer Pharmaceuticals

Ltd.3

Galantamine (as

Hydrobromide)

4mg Tablet REMINYL Shire Pharmaceuticals

Limited2

Not available

locally

RAZADYNE Janssen Pharmaceuticals

Inc.3

8mg Tablet REMINYL Shire Pharmaceuticals

Limited2

Not available

locally

RAZADYNE Janssen Pharmaceuticals

Inc.3

12mg Tablet REMINYL Shire Pharmaceuticals

Limited2

Not available

locally

RAZADYNE Janssen Pharmaceuticals

Inc.3

8mg Prolonged-

/Extended-Release

Capsule

REMINYL XL Shire Pharmaceuticals

Limited2

Not available

locally

RAZADYNE

ER

Janssen Pharmaceuticals

Inc.3

16mg Prolonged-

/Extended-Release

Capsule

REMINYL XL Shire Pharmaceuticals

Limited2

Not available

locally

RAZADYNE

ER

Janssen Pharmaceuticals

Inc.3

24mg Prolonged-

/Extended-Release

Capsule

REMINYL XL Shire Pharmaceuticals

Limited2

Not available

locally

RAZADYNE

ER

Janssen Pharmaceuticals

Inc.3

Gefitinib 250 mg Tablet IRESSA AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co. Ltd. –

China/AstraZeneca UK

Ltd. – United Kingdom]

DR-XY28953

Gemfibrozil 300 mg Capsule LOPID Pfizer, Inc. [PT. Bayer

Indonesia Tbk. –

Indonesia]

DRP-2004

(DR-XY2110)

600 mg Tablet LOPID Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-2003

(DR-XY16208)

900 mg Tablet LOPID OD Pfizer, Inc. [Pfizer

Manufacturing

DRP-2105

(DR-XY15309)

Page 58:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

58

Deutschland GmbH –

Germany]

Gestodene +

Ethinylestradiol

60mcg/15mcg

Tablet

MINESSE Wyeth2 Not available

locally

75mcg/20mcg

Tablet

FEMODETTE/

MILLINETTE

Bayer2 Not available

locally [Schering do Brasil

Quimica e Farmaceutica

Ltda – Brazil]

75mcg/30mcg

Tablet

GYNERA Bayer Philippines, Inc.

[Schering do Brasil

Quimica e Farmaceutica

Ltda – Brazil]

DR-XY25163

Glibenclamide 1.25mg Tablet DIABETA Sanofi Aventis US LLC3 Not available

locally

1.5mg Tablet GLYNASE Pharmacia and Upjohn Co3 Not available

locally

2.5 mg Tablet SEMI-

EUGLUCON

Roche (Phils.), Inc.

[Patheon Italia S.p.A. –

Italy]

DR-7919

DIABETA Sanofi Aventis US LLC3 Not available

locally

3mg Tablet GLYNASE Pharmacia and Upjohn Co3 Not available

locally

5 mg Tablet DAONIL Sanofi-Aventis Phils., Inc.

[Handok Pharm’ls Co. Ltd.

– Korea]

DR-1712

DAONIL Sanofi-Aventis Phils., Inc.

[PT. Aventis Pharma

Indonesia – Indonesia]

DRP-087

EUGLUCON Roche (Phils.), Inc.

[Interphil Labs., Inc.]

DR-1713

6mg Tablet GLYNASE Pharmacia and Upjohn Co3 Not available

locally

Gliclazide 80 mg Tablet DIANORM Merck, Inc. (Phils.)

[Alphapharm Pty. Ltd. –

Australia]

DR-XY29814

30 mg Modified-

Release Tablet

DIAMICRON

MR

Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY25281

60 mg Modified-

Release Tablet

DIAMICRON

MR

Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY38522

80 mg Modified-

Release Tablet

DIAMICRON Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-X626

Page 59:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

59

Glimepiride 1 mg Tablet SOLOSA Sanofi-Aventis Phils., Inc.

[Sanofi-Aventis S.p.A. –

Italy]

DRP-006

2 mg Tablet SOLOSA Sanofi-Aventis Phils., Inc.

[Sanofi-Aventis S.p.A. –

Italy]

DRP-007

(DR-XY24736)

3 mg Tablet SOLOSA Sanofi-Aventis Phils., Inc.

[Sanofi-Aventis S.p.A. –

Italy]

DRP-008

4mg Tablet AMARYL Zentiva2 Not available

locally Sanofi Aventis US LLC3

Glimepiride +

Metformin

hydrochloride

1 mg/250 mg

Tablet

SOLOSAMET Sanofi-Aventis Phils., Inc.

[Handok Pharm’ls Co. Ltd.

– Korea]

DR-XY33865

2 mg/500 mg

Tablet

SOLOSAMET Sanofi-Aventis Phils., Inc.

[Handok Pharm’ls Co. Ltd.

– Korea]

DR-XY33866

2 mg/500 mg

Sustained-Release

Tablet

SOLOSAMET

SR

Sanofi-Aventis Phils., Inc.

[Handok Pharm’ls Co.

Ltd./Handok Inc. – Korea]

DRP-5214

(DR-XY39671)

Glimepiride +

Pioglitazone

Hydrochloride

2mg/30mg Tablet DUETACT Takeda Pharmaceuticals

USA Inc.3

Not available

locally

4mg/30mg Tablet DUETACT Takeda Pharmaceuticals

USA Inc.3

Not available

locally

Glipizide 5 mg Tablet MINIDIAB Pfizer, Inc. [Pfizer Italia

S.r.l. – Italy]

DR-XY31426

10mg Tablet GLUCOTROL Pfizer Inc.3 Not available

locally

2.5mg Extended-

Release Tablet

GLUCOTROL

XL

Pfizer Inc.3 Not available

locally

5 mg Controlled-

Release Tablet

MINIDIAB OD Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-3420

(DR-XY29647)

10 mg Controlled-

Release Tablet

MINIDIAB OD Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-3621

(DR-XY29646)

Guaifenesin

200 mg Softgel

Capsule

ROBITUSSIN Pfizer, Inc. [Catalent

Australia Pty. Ltd. –

Australia]

DR-XY28913

600 mg Extended-

Release Tablet

MUCINEX Zuellig Pharma Corp.

[Reckitt Benckiser, LLC –

USA]

DR-XY39924

Haloperidol 2 mg Tablet HALDOL Johnson & Johnson

(Phils.), Inc.

[Lusomedicamenta-

Sociedade Tecnica

DR-XY23387

Page 60:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

60

Farmaceutica SA –

Portugal]

5 mg Tablet HALDOL Johnson & Johnson

(Phils.), Inc.

[Lusomedicamenta-

Sociedade Tecnica

Farmaceutica SA –

Portugal]

DR-6630

SERENACE Pfizer, Inc. [Piramal

Healthcare UK Ltd. –

United Kingdom]

DRP-1933

10 mg Tablet HALDOL Johnson & Johnson

(Phils.), Inc.

[Lusomedicamenta-

Sociedade Tecnica

Farmaceutica SA –

Portugal]

DR-X6733

20 mg Tablet SERENACE Pfizer, Inc. [Piramal

Healthcare UK Ltd. –

United Kingdom]

DRP-1975

Hydrochlorothiazide 12.5 mg Tablet HYTAZ Therapharma, Inc.

[Amherst Labs., Inc.]

DR-XY30440

25 mg Tablet HYTAZ Therapharma, Inc.

[Amherst Labs., Inc.]

DR-XY30255

12.5mg Capsule MICROZIDE Allergan Sales LLC3 Not available

locally

Hydroxychloroquine

sulfate

200 mg Tablet PLAQUENIL Sanofi-Aventis Phils., Inc.

[Sanofi-Synthelabo Ltd. –

United Kingdom/Sanofi

Aventis S.A. – Spain]

DR-XY20092

Hydroxycarbamide

(Hydroxyurea)

200 mg Capsule DROXIA Bristol-Myers Squibb Co.3 Not available

locally

300 mg Capsule DROXIA Bristol-Myers Squibb Co.3 Not available

locally

400 mg Capsule DROXIA Bristol-Myers Squibb Co.3 Not available

locally

500 mg Capsule HYDREA E.R. Squibb & Sons

Limited2

Not available

locally

Bristol-Myers Squibb Co.3

Hydroxyzine

Hydrochloride

10mg Tablet ITERAX GlaxoSmithKline

Philippines Inc. [UCB

Pharma S.A.- Belgium]

DR-X5123

25mg Tablet ITERAX GlaxoSmithKline

Philippines Inc. [UCB

Pharma S.A.- Belgium]

DR-XY33771

25mg Capsule VISTARIL Pfizer Laboratories Div.

Pfizer Inc.3

Not available

locally

Page 61:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

61

Hydroxyzine

Hydrochloride (as

Pamoate)

50mg Capsule VISTARIL Pfizer Laboratories Div.

Pfizer Inc.3

Not available

locally

Hyoscine

butylbromide

10 mg Tablet BUSCOPAN Boehringer Ingelheim

(Phil.), Inc. [Interphil

Labs., Inc.]

DR-1760

BUSCOPAN Boehringer Ingelheim

(Phil.), Inc. [PT.

Boehringer Ingelheim

Indonesia – Indonesia]

DR-XY41205

Hyoscine

butylbromide +

Paracetamol

10 mg/500 mg

Tablet

BUSCOPAN

PLUS

Boehringer Ingelheim

(Phil.), Inc. [PT.

Boehringer Ingelheim

Indonesia – Indonesia]

DRP-3039

(DR-XY1774)

Ibandronic Acid (as

Sodium

Monohydrate)

50 mg Tablet BONDRONAT Roche (Phils.), Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY31246

BONDRONAT Roche (Phils.), Inc.

[Productos Roche S.A. de

C.V. – Mexico]

DR-XY42448

150 mg Tablet BONVIVA Nycomed Phils. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY39024

Ibuprofen 200 mg Tablet MEDICOL Myra Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY24958

MIDOL A. Menarini Philippines,

Inc. [Swisspharma

Research Labs., Inc.]

DR-XY30477

400 mg Tablet MEDICOL I-400 Myra Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY24952

MIDOL A. Menarini Philippines,

Inc. [Swisspharma

Research Labs., Inc.]

DR-XY32216

600 mg Tablet BRUFEN Abbott Labs. [PT. Abbott

Indonesia – Indoneisa]

DR-XY40727

200 mg Softgel

Capsule

ADVIL Pfizer, Inc. [Catalent

Australia Pty. Ltd –

Australia]

DR-XY32938

400 mg Softgel

Capsule

MEDICOL

ADVANCE 400

Myra Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY41760

100 mg/2.5 mL

Oral Suspension

DOLAN FP Pediatrica, Inc. [United

Labs., Inc.]

DR-XY36588

100 mg/5 mL Oral

Suspension

DOLAN FP Pediatrica, Inc. [Amherst

Labs., Inc.]

DR-XY23908

200 mg/5 mL Oral

Suspension

DOLAN FP

FORTE

Pediatrica, Inc. [Amherst

Labs., Inc.]

DR-XY30816

Page 62:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

62

Ibuprofen +

Paracetamol

200 mg/325 mg

Tablet

ALAXAN Therapharma, Inc. [United

Labs., Inc.]

DR-2318

ALAXAN United Labs., Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY37938

MUSKELAX United Home Products

[Amherst Labs., Inc.]

DR-XY13304

RESTOLAX EuroHealth Care

Exponents, Inc. [Lloyd

Labs., Inc.]

DR-XY24007

400 mg/325 mg

Tablet

RESTOLAX

FORTE

EuroHealth Care

Exponents, Inc. [Lloyd

Labs., Inc.]

DRP-2626

(DR-XY28952)

200 mg/325 mg

Capsule

ALAXAN FR Therapharma, Inc. [United

Labs., Inc.]

DR-XY27687

200 mg/325 mg

Capsule

ALAXAN FR United Labs., Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY37939

Imatinib (as mesilate) 100 mg Tablet

GLIVEC

Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Stein AG – Switzerland]

DR-XY30156

Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Produktions GmbH –

Germany]

400 mg Tablet GLIVEC Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Stein AG – Switzerland]

DR-XY30155

Imidapril

Hydrochloride

5mg Tablet TANATRIL Mitsubishi Tanabe Pharma

Europe Ltd.2

Not available

locally

10mg Tablet TANATRIL Mitsubishi Tanabe Pharma

Europe Ltd.2

Not available

locally

20mg Tablet TANATRIL Mitsubishi Tanabe Pharma

Europe Ltd.2

Not available

locally

Indapamide 1.5 mg Prolonged-

Release Tablet

NATRILIX SR Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY21781

Indapamide

hemihydrate

2.5mg Tablet NATRILIX Servier Laboratories

Limited2

Not available

locally

Indapamide +

Amlodipine besilate

1.5 mg/5 mg

Modified-Release

Tablet

NATRIXAM Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY44704

1.5 mg/10 mg

Modified-Release

Tablet

NATRIXAM Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY44705

Indinavir (as sulfate) 200mg Capsule CRIXIVAN Merck Sharp & Dohme

Corp.2

Not available

locally

Page 63:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

63

400 mg Capsule CRIXIVAN Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Corp. – USA]

DR-XY23211

Inosine acedoben

dimepranol (Inosine

pranobex)

500 mg Tablet IMUNOVIR Kora Healthcare2 Not available

locally

Irbesartan 75mg Tablet APROVEL Sanofi2 Not available

locally AVAPRO Sanofi Aventis US LLC3

150 mg Tablet APROVEL Sanofi-Aventis Phils., Inc.

[Sanofi Winthrop Industrie

– France]

DRP-5716

(DR-XY24039)

300 mg Tablet APROVEL Sanofi-Aventis Phils., Inc.

[Sanofi Winthrop Industrie

– France]

DRP-5715

(DR-XY24038)

Irbesartan +

Amlodipine (as

Besilate)

150mg/5mg Tablet APROVASC Sanofi-Aventis Philippines,

Inc. [Sanofi-Aventis De

Mexico, S.A. de C.V. –

Mexico]

DR-XY45509

300mg/5mg Tablet APROVASC Sanofi-Aventis Philippines,

Inc. [Sanofi-Aventis De

Mexico, S.A. de C.V. –

Mexico]

DR-XY45507

150mg/5mg Tablet APROVASC Sanofi-Aventis Philippines,

Inc. [Sanofi-Aventis De

Mexico, S.A. de C.V. –

Mexico]

DR-XY45508

Irbesartan +

Hydrochlorothiazide

150 mg/12.5 mg

Tablet

CO-APROVEL Sanofi-Aventis Phils., Inc.

[Sanofi Winthrop Industrie

– France]

DRP-001

300 mg/12.5 mg

Tablet

CO-APROVEL Sanofi-Aventis Phils., Inc.

[Sanofi Winthrop Industrie

– France]

DRP-002

300 mg/25 mg

Tablet

CO-APROVEL Sanofi-Aventis Phils., Inc.

[Sanofi Winthrop Industrie

– France]

DRP-5717

(DR-XY34372)

Isoniazid 100 mg Tablet ISOZID Fatol2 Not available

locally Unbranded Sandoz Inc.3

Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-5058

300 mg Tablet Unbranded Sandoz Inc.3 Not available

locally

Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-X9633

Isosorbide dinitrate 5 mg Tablet

(Oral/Sublingual)

ISOKET GlaxoSmithKline Phils.,

Inc. [Aesica Pharm’ls

GmbH – Germany]

DR-XY6936

Page 64:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

64

5 mg Sublingual

Tablet

ISORDIL Pfizer, Inc. [Interphil

Labs., Inc.]

DR-XY6510

ISORDIL Pfizer, Inc. [Interphil

Labs., Inc.]

DR-XY39155

10 mg Tablet

(Oral/Sublingual)

ISOKET GlaxoSmithKline Phils.,

Inc. [Aesica Pharm’ls

GmbH – Germany]

DR-XY6937

10 mg Tablet ISORDIL Pfizer, Inc. [Interphil

Labs., Inc.]

DR-XY6511

ISORDIL Pfizer, Inc. [Interphil

Labs., Inc.]

DR-XY38979

20 mg Sustained-

Release Tablet

ISOKET GlaxoSmithKline Phils.,

Inc. [Aesica Pharm’ls

GmbH – Germany]

DR-XY6938

40 mg Sustained-

Release Tablet

ISOKET GlaxoSmithKline Phils.,

Inc. [Aesica Pharm’ls

GmbH – Germany]

DR-XY6939

40mg Tablet ISORDIL Valeant Pharmaceuticals

North America LLC3

Not available

locally

40mg Extended-

Release Capsule

DILATRATE-

SR

Auxilium Pharmaceuticals

LLC3

Not available

locally

Isosorbide

mononitrate

10mg Tablet MONOKET Kremers Urban

Pharmaceuticals Inc.3

Not available

locally

20 mg Tablet ELANTAN 20 GlaxoSmithKline Phils.,

Inc. [Schwarz Pharma AG

– Germany]

DR-XY6943

ELANTAN 20 GlaxoSmithKline Phils.,

Inc. [Aesica Pharm’ls

GmbH – Germany]

DR-XY6943

30 mg Tablet IMDUR

DURULES

AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co., Ltd. – China]

DR-XY25446

40 mg Tablet ELANTAN 40 GlaxoSmithKline Phils.,

Inc. [Schwarz Pharma AG

– Germany]

DR-XY6944

ELANTAN 40 GlaxoSmithKline Phils.,

Inc. [Aesica Pharm’ls

GmbH – Germany]

DR-XY6944

60 mg Extended-

Release Tablet

IMDUR

DURULES

AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co., Ltd. – China]

DR-XY23150

ELANTAN GlaxoSmithKline Phils.,

Inc. [Schwarz Pharma

Manufacturing, Inc. –

USA]

DR-XY27369

Page 65:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

65

50 mg Extended-

Release Capsule

ELANTAN GlaxoSmithKline Phils.,

Inc. [Schwarz Pharma AG

– Germany]

DR-XY7878

Isotretinoin 10 mg Softgel

Capsule

ROACCUTANE Roche (Philippines), Inc.

[F. Hoffman La Roche Ltd.

– Germany]

DR-XY2847

20 mg Softgel

Capsule

ACCUTANE/

ROACCUTANE

Roche2, 3 Not available

locally

Isoxsuprine

hydrochloride

10 mg Tablet DUVADILAN Abbott Products (Phils.),

Inc. [Interphil Labs., Inc.]

DR-7352

Itopride

hydrochloride

50 mg Tablet GANATON Abbott Labs. [Abbott

Japan Co., Ltd.

(Katsuyama) – Japan]

DR-XY32773

Itraconazole 100mg Capsule SPORANOX Johnson & Johnson (Phils.)

Inc. [Janssen Korea Ltd. –

Korea]

DR-XY38258

Ivabradine 5 mg Tablet CORALAN Servier Philippines, Inc.

[Les Laboratoires Servier

Industrie – France]

DR-XY32013

7.5 mg Tablet CORALAN Servier Philippines, Inc.

[Les Laboratoires Servier

Industrie – France]

DR-XY32012

Ketoprofen 50mg Capsule PROFENID/

ORUDIS

Sanofi2 Not available

locally

100mg Capsule PROFENID/

ORUDIS

Sanofi2 Not available

locally

100mg Prolonged-

Release Capsule

ORUVAIL Sanofi2 Not available

locally

200mg Prolonged-

Release Capsule

ORUVAIL Sanofi2 Not available

locally

Ketorolac trometamol 10 mg Tablet TORADOL/

ACULAR

Roche2, 3 ,4 Not available

locally

Ketotifen fumarate 1 mg Tablet ZADEC Novartis Healthcare Phils.,

Inc. [Novartis Pharm’ls

UK Ltd. – United

Kingdom]

DR-XY25657

2 mg Modified-

Release Tablet

ZADEC SRO Novartis Healthcare Phils.,

Inc. [Novartis Farma

S.p.A. – Italy]

DRP-4573

(DR-XY15842)

ZADITEN SRO Sandoz Phils. Corp

[Novartis Farma S.p.A. –

Italy]

DR-XY16874

Lacidipine 2 mg Tablet LACIPIL GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome S.A.

– Spain]

DR-XY16826

Page 66:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

66

4 mg Tablet LACIPIL GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome S.A.

– Spain]

DR-XY16827

6 mg Tablet LACIPIL GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome S.A.

– Spain]

DR-XY29222

Lacosamide 50mg Tablet VIMPAT Abbott Labs. Phils., Inc.

[Aesica Pharmaceutical

GmbH – Germany]

DR-XY43096

100mg Tablet VIMPAT Abbott Labs. Phils., Inc.

[Aesica Pharmaceutical

GmbH – Germany]

DR-XY43253

150mg Tablet VIMPAT Abbott Labs. Phils., Inc.

[Aesica Pharmaceutical

GmbH – Germany]

DR-XY42787

200mg Tablet VIMPAT Abbott Labs. Phils., Inc.

[Aesica Pharmaceutical

GmbH – Germany]

DR-XY43228

Lamivudine 100mg Tablet ZEFFIX GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Operations – United

Kingdom]

DR-XY24459

150mg Tablet EPIVIR ViiV Healthcare UK Ltd.2 Not available

locally ViiV Healthcare Co.3

300mg Tablet EPIVIR ViiV Healthcare UK Ltd.2 Not available

locally ViiV Healthcare Co.3

Lamivudine +

Tenofovir disoproxil

fumarate

300mg/300mg

Tablet

CIMDUO Mylan Laboratories Ltd.3 Not available

locally

Lamivudine +

Zidovudine

150mg/300mg

Tablet

COMBIVIR GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Pharmaceuticals SA –

Poland]

DR-XY24557

Lamotrigine 2mg Chewable

Tablet

LAMICTAL GlaxoSmithKline UK2 Not available

locally GlaxoSmithKline LLC3

5 mg Chewable

Tablet

LAMICTAL GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Pharm’ls S.A. – Poland]

DR-XY20977

25mg Chewable

Tablet

LAMICTAL GlaxoSmithKline UK2 Not available

locally GlaxoSmithKline LLC3

100mg Chewable

Tablet

LAMICTAL GlaxoSmithKline UK2 Not available

locally

25 mg Dispersible

Tablet

LAMICTAL GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Pharm’ls S.A. – Poland]

DR-XY20983

50mg Dispersible

Tablet

LAMICTAL

ODT

GlaxoSmithKline LLC3 Not available

locally

Page 67:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

67

100mg Dispersible

Tablet

LAMICTAL GlaxoSmithKline UK2 Not available

locally LAMICTAL

ODT

GlaxoSmithKline LLC3

200mg Dispersible

Tablet

LAMICTAL

ODT

GlaxoSmithKline LLC3 Not available

locally

25mg Tablet LAMICTAL GlaxoSmithKline UK2 Not available

locally GlaxoSmithKline LLC3

50 mg Tablet LAMICTAL GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Pharm’ls S.A. – Poland]

DR-XY17652

100 mg Tablet LAMICTAL GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Pharm’ls S.A. – Poland]

DR-XY17653

150mg Tablet LAMICTAL GlaxoSmithKline LLC3 Not available

locally

200mg Tablet LAMICTAL GlaxoSmithKline UK2 Not available

locally GlaxoSmithKline LLC3

25 mg Extended-

Release Tablet

LAMICTAL XR GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY41511

50 mg Extended-

Release Tablet

LAMICTAL XR GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY41513

100 mg Extended-

Release Tablet

LAMICTAL XR GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY41509

200 mg Extended-

Release Tablet

LAMICTAL XR GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY41512

300 mg Extended-

Release Tablet

LAMICTAL XR GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY41510

Lansoprazole 15 mg Delayed-

Release Capsule

PREVACID Takeda Pharm’ls (Phils.),

Inc. [E.L. Labs., Inc.]

DR-XY27389

30 mg Delayed-

Release Capsule

PREVACID Takeda Pharm’ls (Phils.),

Inc. [E.L. Labs., Inc.]

DR-XY20370

15 mg Orally

Disintegrating

Tablet

PREVACID

FDT

Takeda Pharm’ls (Phils.),

Inc. [Kokando Co., Ltd. –

Japan]

DR-XY29627

30 mg Orally

Disintegrating

Tablet

PREVACID

FDT

Takeda Pharm’ls (Phils.),

Inc. [Kokando Co., Ltd. –

Japan]

DR-XY29628

Lanthanum (as

carbonate)

500 mg Chewable

Tablet

FOSRENOL A. Menarini Phils., Inc.

[Hamol Ltd. – United

Kingdom]

DR-XY34773

750mg Chewable

Tablet

FOSRENOL Shire Pharmaceuticals

Ltd.2

Not available

locally

Page 68:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

68

Shire Development LLC3

1g Chewable

Tablet

FOSRENOL Shire Pharmaceuticals

Ltd.2

Not available

locally

Shire Development LLC3

750mg Chewable

Tablet

FOSRENOL Shire Pharmaceuticals

Ltd.2

Not available

locally

Shire Development LLC3

1g Chewable

Tablet

FOSRENOL Shire Pharmaceuticals

Ltd.2

Not available

locally

Shire Development LLC3

Lapatinib (as

Ditosilate)

250mg Tablet TYVERB Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

TYKERB Novartis Pharmaceuticals

Corp.3

Ledipasvir +

Sofosbuvir

90mg/400mg

Tablet

HARVONI LF Asia (Philippines), Inc.

[Patheon Inc. – Canada]

DR-XY45887

Leflunomide 10mg Tablet ARAVA Sanofi2 Not available

locally Sanofi Aventis US LLC3

20mg Tablet ARAVA Sanofi-Aventis Philippines,

Inc. [Sanofi Winthrop

Industries – France]

DR-XY27151

100mg Tablet ARAVA Sanofi2 Not available

locally Sanofi Aventis US LLC3

Lenalidomide 2.5mg Capsule REVLIMID Celgene Ltd.2 Not available

locally Celgene Corp.3

5mg Capsule REVLIMID Celgene Ltd.2 Not available

locally Celgene Corp.3

7.5mg Capsule REVLIMID Celgene Ltd.2 Not available

locally

10mg Capsule REVLIMID Celgene Ltd.2 Not available

locally Celgene Corp.3

15mg Capsule REVLIMID Celgene Ltd.2 Not available

locally Celgene Corp.3

20mg Capsule REVLIMID Celgene Ltd.2 Not available

locally Celgene Corp.3

25mg Capsule REVLIMID Celgene Ltd.2 Not available

locally Celgene Corp.3

Lenvatinib (as

Mesilate)

4mg Capsule LENVIMA Hi-Eisai Pharmaceutical,

Inc. [Patheon Inc. –

Canada]

Not available

locally

10mg Capsule LENVIMA Hi-Eisai Pharmaceutical,

Inc. [Patheon Inc. –

Canada]

Not available

locally

Lercanidipine

Hydrochloride

10mg Tablet ZANIDIP Abbott Products

(Philippines), Inc.

DR-XY25482

Page 69:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

69

[Recordati Industria Chiica

e Farmaceutica S.p.A. –

Italy]

20mg Tablet ZANIDIP Recordati Pharmaceuticals

Limited2

Not available

locally

Letrozole 2.5mg Tablet FEMARA Novartis Healthcare Phils.

Inc. [Novartis Pharma

Stein AG – Switzerland]

DR-XY23757

Levetiracetam 250 mg Tablet KEPPRA GlaxoSmithKline Phils.,

Inc. [UCB Pharma S.A. –

Belgium]

DR-XY29934

500 mg Tablet KEPPRA GlaxoSmithKline Phils.,

Inc. [UCB Pharma S.A. –

Belgium]

DR-XY29131

750 mg Tablet KEPPRA UCB Pharma Limited2 Not available

locally UCB Inc.3

1 g Tablet KEPPRA GlaxoSmithKline Phils.,

Inc. [UCB Pharma S.A. –

Belgium]

DR-XY29122

500mg Extended-

Release Tablet

KEPPRA XR UCB Inc.3 Not available

locally

750mg Extended-

Release Tablet

KEPPRA XR UCB Inc.3 Not available

locally

Levocetirizine

Hydrochloride

5mg Tablet XYZAL GlaxoSmithKline

Philippines, Inc. [UCB

Farchim S.A. –

Switzerland]

DR-XY28008

Levodopa +

Benserazide (as

Hydrochloride)

50mg/12.5mg

Dispersible Tablet

MADOPAR Roche Products Limited2 Not available

locally

100mg/25mg

Dispersible Tablet

MADOPAR Roche Products Limited2 Not available

locally

200mg/50mg

Tablet

MADOPAR Roche Phils., Inc. [Roche

S.p.A. – Italy]

DR-XY40579

50mg/12.5mg

Capsule

MADOPAR Roche Products Limited2 Not available

locally

100mg/25mg

Capsule

MADOPAR

HBS

Roche Phils., Inc. [Roche

S.p.A. – Italy]

DR-XY40316

Roche Phils., Inc. [F.

Hoffmann La Roche Ltd. –

Switzerland]

DR-XY7155

200mg/50mg

Capsule

MADOPAR Roche Products Limited2 Not available

locally

200mg/50mg

Prolonged-Release

Capsule

MADOPAR CR Roche Products Limited2 Not available

locally

50mg/12.5mg

Tablet

SINEMET Merck Sharp & Dohme

Limited2

Not available

locally

Page 70:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

70

Levodopa +

Carbidopa (as

monohydrate)

100mg/10mg

Tablet

SINEMET Merck Sharp & Dohme

Limited2

Not available

locally

Merck Sharp and Dohme

Corp.3

100 mg/25 mg

Tablet

SINEMET Merck Sharp & Dohme

(I.A.) Corp. [Mylan

Pharm’ls Inc. –USA]

DR-XY14285

250 mg/25 mg

Tablet

SINEMET Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme (Australia) Pty.

Ltd. – Australia]

DR-9001

100mg/25mg

Extended-Release

Tablet

SINEMET CR Merck Sharp & Dohme

Limited2

Not available

locally

HALF

SINEMET CR

Merck Sharp and Dohme

Corp.3

200 mg/50 mg

Sustained-Release

Tablet

SINEMET CR Merck Sharp & Dohme

(I.A.) Corp. [Mylan

Pharm’ls Inc. –USA]

DR-XY17909

95mg/23.75mg

Extended-Release

Capsule

RYTARY Impax Laboratories Inc.3 Not available

locally

145mg/36.25mg

Extended-Release

Capsule

RYTARY Impax Laboratories Inc.3 Not available

locally

195mg/48.75mg

Extended-Release

Capsule

RYTARY Impax Laboratories Inc.3 Not available

locally

245mg/61.25mg

Extended-Release

Capsule

RYTARY Impax Laboratories Inc.3 Not available

locally

Levodopa +

Carbidopa (as

monohydrate) +

Entacapone

50 mg/12.5

mg/200 mg Tablet

STALEV Novartis Healthcare Phils.,

Inc. [Orion Corp. –

Finland]

DR-XY30843

75mg/18.75mg/

200mg Tablet

STALEV Novartis Healthcare Phils.,

Inc. [Orion Corp. –

Finland]

DR-XY39661

100 mg/25 mg/200

mg Tablet

STALEV Novartis Healthcare Phils.,

Inc. [Orion Corp. –

Finland]

DR-XY30841

125mg/31.25mg/

200mg Tablet

STALEV Novartis Healthcare Phils.,

Inc. [Orion Corp. –

Finland]

DR-XY39662

150 mg/37.5

mg/200 mg Tablet

STALEV Novartis Healthcare Phils.,

Inc. [Orion Corp. –

Finland]

DR-XY30842

175mg/43.75mg/

200mg Tablet

STALEVO Orion Pharma (UK)

Limited2

Not available

locally

Page 71:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

71

200mg/50mg/

200mg Tablet

STALEVO Orion Pharma (UK)

Limited2

Not available

locally

Orion Pharma3

Levofloxacin (as

Hemihydrate)

250 mg Tablet TAVANIC Sanofi-Aventis2 Not available

locally

LEVAQUIN Janssen Pharmaceuticals,

Inc.3

500 mg Tablet TAVANIC Sanofi-Aventis2 Not available

locally

LEVAQUIN Janssen Pharmaceuticals,

Inc.3

LEVOX Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY23653

FLOXEL United American Pharm’ls,

Inc. [Amherst Labs., Inc.]

DR-XY24334

750 mg Tablet LEVAQUIN Janssen Pharmaceuticals,

Inc.3

Not available

locally

LEVOX Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY32085

FLOXEL United American Pharm’ls,

Inc. [Amherst Labs., Inc.]

DR-XY32172

Levomilnacipran (as

Hydrochloride)

20mg Extended-

Release Capsule

FETZIMA Allergan Sales LLC3 Not available

locally

40mg Extended-

Release Capsule

FETZIMA Allergan Sales LLC3 Not available

locally

80mg Extended-

Release Capsule

FETZIMA Allergan Sales LLC3 Not available

locally

120mg Extended-

Release Capsule

FETZIMA Allergan Sales LLC3 Not available

locally

Levonorgestrel +

Ethinylestradiol

125 mcg/30 mcg

Tablet with

Ferrous Fumarate

75 mg Tablet

TRUST PILL DKT Phils., Inc. [Pond’s

Chemical Thailand R.O.P.

– Thailand]

DRP-336

(DR-XY21773)

150 mcg/30 mcg

Tablet

SEIF Bayer Phils., Inc. [Schering

do Brasil – Brazil]

DR-XY8804

NORDETTE Pfizer, Inc. [Wyeth Medica

Ireland Ltd. – Ireland]

DR-XY23241

MICROGYNON

30

Bayer plc/Schering AG2 Not available

locally

250 mcg/50 mcg

Tablet

NORDIOL 21 Pfizer, Inc. [Wyeth Medica

Ireland Ltd. – Ireland]

DR-XY22610

50 mcg/30 mcg

Tablet; 75 mcg/40

mcg Tablet; 125

mcg/30 mcg

Tablet

TRINORDIOL Pfizer, Inc. [Wyeth Medica

Ireland Ltd. – Ireland]

DR-XY3927

LOGYNON Bayer Phils., Inc. [Bayer

Weimar GmbH und Co.

KG – Germany]

DR-XY9421

Levothyroxine

sodium

25 mcg Tablet THYRAX

DUOTAB

Aspen Phils., Inc. [N.V.

Organon – Netherlands]

DR-XY21847

Page 72:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

72

SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38842

EUTHYROX 25 Merck, Inc. [Merck S.A. de

C.V. – Mexico]

DR-XY29755

50 mcg Tablet ELTROXIN Aspen Phils., Inc. [Aspen

Bad Oldesloe GmbH –

Germany]

DR-9961

SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38835

EUTHYROX Merck, Inc. [Merck S.A. de

C.V. – Mexico]

DR-XY30013

75mcg Tablet SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38834

88mcg Tablet SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38837

100 mcg Tablet ELTROXIN Aspen Phils., Inc. [Aspen

Bad Oldesloe GmbH –

Germany]

DR-9962

THYRAX

DUOTAB

Aspen Phils., Inc. [N.V.

Organon – Netherlands]

DR-XY21848

Aspen Phils. Inc. [P.T.

Sydna Farma – Indonesia]

DR-XY31487

SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38836

EUTHYROX

100

Merck, Inc. [Merck S.A. de

C.V. – Mexico]

DR-XY30009

112mcg Tablet SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38845

125mcg Tablet SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY33856

137mcg Tablet SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY33864

150 mcg Tablet THYRAX

DUOTAB

Aspen Phils., Inc. [N.V.

Organon – Netherlands]

DR-XY21849

SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38853

EUTHYROX Merck, Inc. [Merck S.A. de

C.V. – Mexico]

DR-XY34425

175mcg Tablet SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38852

200mcg Tablet SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38846

300mcg Tablet SYNTHROID Abbott Labs. [Abbott Labs.

– Puerto Rico]

DR-XY38851

12.5mg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

Page 73:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

73

25mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

50mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

75mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

88mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

100mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

112mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

125mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

137mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

150mcg Capsule TIROSINT Institut Biochimique SA

(IBSA)3

Not available

locally

Linagliptin 5mg Tablet TRAJENTA Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Roxane, Inc. –

USA]

DR-XY40708

Linagliptin +

Metformin

Hydrochloride

2.5mg/500mg

Tablet

TRAJENTA

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY42181

2.5mg/850mg

Tablet

TRAJENTA

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY42180

2.5mg/1g Tablet TRAJENTA

DUO

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY42182

2.5mg/1g

Extended-Release

Tablet

JENTADUETO

XR

Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

5mg/1g Extended-

Release Tablet

JENTADUETO

XR

Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

Linezolid 600 mg Tablet ZYVOX Pfizer, Inc. [Pfizer

Pharmaceuticals LLC –

Puerto Rico]

DR-XY27448

100 mg/5 mL

Powder for Oral

Suspension

ZYVOX Pfizer, Inc. [Pfizer

Pharmaceuticals LLC –

Puerto Rico]

DR-XY27447

ZYVOX Pfizer, Inc. [Pharmacia &

Upjohn – USA]

DR-XY38947

Page 74:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

74

Lisinopril 2.5mg Tablet ZESTRIL Alvogen Malta Operations

Ltd.3

Not available

locally

5mg Tablet ZESTRIL AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca Pharm’l.

Co., Ltd. – China]

DR-XY14851

10mg Tablet ZESTRIL AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca Pharm’l.

Co., Ltd. – China]

DR-XY14853

20mg Tablet ZESTRIL AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca Pharm’l.

Co., Ltd. – China]

DR-XY14852

30mg Tablet ZESTRIL Alvogen Malta Operations

Ltd.3

Not available

locally

40mg Tablet ZESTRIL Alvogen Malta Operations

Ltd.3

Not available

locally

Lisinopril +

Hydrochlorothiazide

10mg/12.5mg

Tablet

ZESTORETIC

10

AstraZeneca UK Limited2 Not available

locally

ZESTORETIC Alvogen Malta Operations

Ltd.3

20mg/12.5mg

Tablet

ZESTORETIC AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca UK Ltd.

– United Kingdom]

DR-XY19913

20mg/25mg Tablet ZESTORETIC Alvogen Malta Operations

Ltd.3

Not available

locally

Lithium Carbonate 150mg Capsule LITHIUM

CARBONATE

West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

300mg Capsule LITHIUM

CARBONATE

West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

600mg Capsule LITHIUM

CARBONATE

West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

300mg Tablet LITHIUM

CARBONATE

West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

300mg Extended-

Release Tablet

LITHOBID Ani Pharmaceuticals Inc.3 Not available

locally

Loperamide

hydrochloride

2 mg Capsule

IMODIUM Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY14916

LORMIDE United Home Products

[Amherst Labs., Inc.]

DR-X6084

Page 75:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

75

DIATABS Biomedis, Inc. [United

Labs., Inc.]

DR-XY24964

2 mg Tablet LOMOTIL Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY27914

Lopinavir + Ritonavir 100mg/25mg

Tablet

KALETRA AbbVie Limited2 Not available

locally Abbvie Inc.3

200 mg/50 mg

Tablet

ALUVIA Abbott Labs. [Abbott

GmbH & Co. KG –

Germany]

DR-XY35003

Loratadine 10 mg Tablet CLARITIN Organon Phils., Inc.

[Schering-Plough Labo

N.V. – Belgium]

DRP-3596

ALLERTA United American Pharm’ls,

Inc. [Amherst Labs., Inc.]

DR-XY29925

5mg Orally

Disintegration

Tablet

CLARITIN

REDITABS

Bayer Healthcare LLC3 Not available

locally

10 mg Orally

Disintegrating

Tablet

CLARITIN

REDITABS

Organon Phils., Inc.

[Catalent UK Swindon

Zydis Ltd. – United

Kingdom]

DR-XY43946

Loratadine +

Pseudoephedrine

Sulfate

5mg/120mg

Extended-Release

Tablet

CLARITIN-D Bayer Healthcare LLC3 Not available

locally

10mg/240mg

Extended-Release

Tablet

CLARITIN-D Bayer Healthcare LLC3 Not available

locally

Losartan potassium 12.5mg Tablet COZAAR Merck Sharp and Dohme

Limited2

Not available

locally

25mg Tablet COZAAR Merck Sharp and Dohme

Limited2

Not available

locally

Merck Sharp and Dohme

Corp.3

50 mg Tablet COZAAR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-6249

(DR-XY21196)

100 mg Tablet COZAAR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-6250

(DR-XY28142)

2.5mg/mL Powder

for Oral

Suspension

COZAAR Merck Sharp and Dohme

Limited2

Not available

locally

Page 76:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

76

Losartan potassium +

Amlodipine camsilate

50 mg/5 mg Tablet COZAAR XQ Merck Sharp & Dohme

(I.A.) Corp. [Hanmi

Pharm’l Co., Ltd. – Korea]

DR-XY40907

100 mg/5 mg

Tablet

COZAAR XQ Merck Sharp & Dohme

(I.A.) Corp. [Hanmi

Pharm’l Co., Ltd. – Korea]

DRP-5347

(DR-XY40906)

Losartan potassium +

Hydrochlorothiazide

50 mg/12.5 mg

Tablet

HYZAAR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DR-XY24847

100 mg/12.5 mg

Tablet

HYZAAR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DR-XY34041

100 mg/25 mg

Tablet

HYZAAR DS Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DR-XY27120

Lynestrenol 500mg Tablet EXLUTON Merck Sharp & Dohme

(I.A.) Corporation. [N.V.

Organon – Netherlands]

DR-XY18077

Macitentan 10mg Tablet OPSUMIT A. Menarini Philippines,

Inc. [Pantheon Italia S.p.A.

– Italy]

DR-XY45565

Mebendazole 100 mg Tablet ANTIOX Johnson & Johnson

(Phils.), Inc. [Xian-Janssen

Pharm’l Ltd. – China]

DR-XY19304

500 mg Chewable

Tablet

ANTIOX

(Chocolate

Flavor)

Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY20154

ANTIOX Johnson & Johnson

(Phils.), Inc. [Janssen

Korea Ltd. – Korea]

DR-XY40801

20 mg/mL (100

mg/5 mL) Oral

Suspension

ANTIOX Johnson & Johnson

(Phils.), Inc. [Janssen

Pharmaceutica N.V. –

Belgium]

DR-X3594

ANTIOX Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY15649

50 mg/mL Oral

Suspension

ANTIOX Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY20534

Medroxyprogesterone

Acetate

2.5mg Tablet PROVERA Pfizer Limited2 Not available

locally Pharmacia and Upjohn

Co.3

5mg Tablet PROVERA Pfizer Limited2

Page 77:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

77

Pharmacia and Upjohn

Co.3

Not available

locally

10mg Tablet PROVERA Pfizer, Inc. [Pfizer Italia

S.r.l. – Italy]

DRP-1934

100mg Tablet PROVERA Pfizer Limited2 Not available

locally

200mg Tablet PROVERA Pfizer Limited2 Not available

locally

400mg Tablet PROVERA Pfizer Limited2 Not available

locally

Mefenamic Acid 250 mg Capsule PONSTAN SF Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2074

(DR-XY29076)

500 mg Capsule PONSTAN SF Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2099

(DR-XY20198)

500 mg Tablet PONSTAN Pfizer, Inc. [PT. Pfizer

Indonesia – Indonesia]

DRP-2092

50 mg/5 mL Oral

Suspension

PONSTAN Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2075

Mefloquine

hydrochloride

250 mg Tablet LARIAM Roche Phils., Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY16323

Megestrol acetate 40 mg Tablet Unbranded Marketlink Int’l Corp.

[Pharmachemie B.V. –

Netherlands]

DR-XY22677

MEGESTROL

ACETATE

Par Pharmaceutical Inc.3 Not available

locally

MEGACE Bristol Myers Squibb3

160 mg Tablet MEGACE Zuellig Pharma Corp.

[Haupt Pharma

Regensburg GmbH –

Germany]

DR-XY7203

MEGAPLEX Pacific Healthcare Phils.,

Inc. [Teva Czech Industries

s. r. o. – Czech Republic]

DR-XY22884

MEGACE Swedish Orphan

Biovitrum2

Not available

locally

40mg/mL Oral

Suspension

MEGESTROL

ACETATE

West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

MEGACE Bristol Myers Squibb3

Meloxicam 7.5 mg Tablet MOBIC Boehringer Ingelheim

(Phil.), Inc. [Interphil

Labs., Inc.]

DR-XY22460

MOBIC Boehringer Ingelheim

(Phil.), Inc. [PT.

Boehringer Ingelheim

Indonesia – Indonesia]

DR-XY41948

Page 78:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

78

15 mg Tablet MOBIC Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY23446

MOBIC Boehringer Ingelheim

(Phil.), Inc. [PT.

Boehringer Ingelheim

Indonesia – Indonesia]

DR-XY41947

5mg Capsule VIVLODEX Iroko Pharmaceuticals

LLC3

Not available

locally

10mg Capsule VIVLODEX Iroko Pharmaceuticals

LLC3

Not available

locally

7.5mg/5mL Oral

Suspension

MOBIC Boehringer Ingelheim

Pharmaceuticals Inc.

Not available

locally

Memantine

hydrochloride

5mg Tablet EBIXA Lundbeck Limited2 Not available

locally NAMENDA Forest Laboratories LLC3

10 mg Tablet ABIXA Metro Drug, Inc.

[Rottendorf Pharma GmbH

– Germany]

DR-XY30750

15mg Tablet EBIXA Lundbeck Limited2 Not available

locally

20 mg Tablet ABIXA Metro Drug, Inc.

[Rottendorf Pharma GmbH

– Germany]

DR-XY36194

7mg Extended-

Release Capsule

NAMENDA XR Forest Laboratories LLC3 Not available

locally

14mg Extended-

Release Capsule

NAMENDA XR Forest Laboratories LLC3 Not available

locally

21mg Extended-

Release Capsule

NAMENDA XR Forest Laboratories LLC3 Not available

locally

28mg Extended-

Release Capsule

NAMENDA XR Forest Laboratories LLC3 Not available

locally

Mercaptopurine 50 mg Tablet PURI-NETHOL Aspen Phils., Inc. [Excella

GmbH – Germany]

DR-272

20mg/mL Oral

Suspension

XALUPRINE Nova Laboratories Ltd.2, 3 Not available

locally PURIXAN

Mesalazine 250mg Enteric-

Coated Tablet

SALOFALK Dr. Falk Pharma UK Ltd.2 Not available

locally

500mg Enteric-

Coated Tablet

SALOFALK A. Menarini Philippines,

Inc. [Losan Pharma GmbH

– Germany]

DR-XY21352

500mg Gastro-

Resistant

Prolonged-Release

Granules

SALOFALK A. Menarini Philippines,

Inc. [Losan Pharma GmbH

– Germany]

DR-XY43333

Page 79:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

79

1g Gastro-

Resistant

Prolonged-Release

Granules

SALOFALK A. Menarini Philippines,

Inc. [Losan Pharma GmbH

– Germany]

DR-XY43336

1.5g Gastro-

Resistant

Prolonged-Release

Granules

SALOFALK A. Menarini Philippines,

Inc. [Losan Pharma GmbH

– Germany]

DR-XY43335

3g Gastro-

Resistant

Prolonged-Release

Granules

SALOFALK A. Menarini Philippines,

Inc. [Losan Pharma GmbH

– Germany]

DR-XY43334

Metformin

hydrochloride

500 mg Tablet GLUCOPHAGE Merck, Inc. [PT. Merck

Tbk. – Indonesia]

DRP-6512

(DR-XY33613)

850 mg Tablet GLUCOPHAGE

FORTE

Merck, Inc. [PT. Merck

Tbk. – Indonesia]

DRP-6510

(DR-XY32220)

1 g Tablet GLUCOPHAGE Merck, Inc. [Merck Sante

S.A.S. – France]

DRP-6511

(DR-XY27551)

500 mg Extended-

Release Tablet

GLUCOPHAGE

XR

Merck, Inc. [Merck Sante

S.A.S. – France]

DRP-6507

(DR-XY32414)

750 mg Extended-

Release Tablet

GLUCOPHAGE

XR

Merck, Inc. [Merck Sante

S.A.S. – France]

DRP-6508

(DR-XY35311)

1 g Extended-

Release Tablet

GLUCOPHAGE

XR

Merck, Inc. [Merck Sante

S.A.S. – France]

DRP-6509

(DR-XY40758)

Metformin

hydrochloride +

Glibenclamide

250 mg/1.25 mg

Tablet

GLUCOVANCE Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY28383

500 mg/2.5 mg

Tablet

GLUCOVANCE Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY28382

500 mg/5 mg

Tablet

GLUCOVANCE Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY28255

1 g/5 mg Tablet GLUCOVANCE Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY41213

400 mg/2.5 mg

Tablet

EUGLO PLUS Roche Phils., Inc. [Patheon

Italia S.p.A. – Italy]

DR-XY31288

Methotrexate (as

sodium)

2.5 mg Tablet EMTHEXATE Pacific Healthcare (Phils.),

Inc. [Teva Czech Industries

s.r.o. – Czech Republic]

DR-XY41270

MAXTREX Pfizer Limited2 Not available

locally Unbranded Dava Pharmaceuticals Inc.3

10mg Tablet MAXTREX Pfizer Limited2 Not available

locally

Methyldopa

250mg Tablet ALDOMET Aspen Philippines, Inc.

[Aspen Port Elizabetg (Pty)

Ltd. – South Africa]

DR-XY39311

500mg Tablet ALDOMET Aspen2 Not available

locally

Page 80:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

80

Methylergometrine

maleate

125 mcg Tablet METHERGIN Novartis Healthcare Phils.,

Inc. [Novartis Pharma

GmbH – Germany]

DRP-1979

(DR-4596)

Methylphenidate

hydrochloride

18 mg Extended-

Release Tablet

CONCERTA Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

Manufacturing LLC –

Puerto Rico]

DR-XY27940

20mg Extended-

Release Tablet

RITALIN-SR Novartis Pharmaceuticals

Corp.3

Not available

locally

27 mg Extended-

Release Tablet

CONCERTA Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

Manufacturing LLC –

Puerto Rico]

DR-XY30659

36 mg Extended-

Release Tablet

CONCERTA Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

Manufacturing LLC –

Puerto Rico]

DR-XY27941

54mg Extended-

Release Tablet

CONCERTA XL Janssen-Cilag Ltd.2 Not available

locally CONCERTA Janssen Pharmaceuticals

Inc.3

5mg Tablet RITALIN Novartis Pharmaceuticals

Corp.3

Not available

locally

10 mg Tablet RITALIN Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY28528

20mg Tablet RITALIN Novartis Pharmaceuticals

Corp.3

Not available

locally

20mg Extended-

Release Chewable

Tablet

QUILLICHEW

ER

Pfizer Inc.3 Not available

locally

30mg Extended-

Release Chewable

Tablet

QUILLICHEW

ER

Pfizer Inc.3 Not available

locally

40mg Extended-

Release Chewable

Tablet

QUILLICHEW

ER

Pfizer Inc.3 Not available

locally

8.6mg Orally

Disintegrating,

Extended-Release

Tablet

COTEMPLA

XR-ODT

Neos Therapeutics Inc.3 Not available

locally

17.3mg Orally

Disintegrating,

Extended-Release

Tablet

COTEMPLA

XR-ODT

Neos Therapeutics Inc.3 Not available

locally

25.9mg Orally

Disintegrating,

COTEMPLA

XR-ODT

Neos Therapeutics Inc.3 Not available

locally

Page 81:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

81

Extended-Release

Tablet

10mg Extended-

Release Capsule

APTENSIO XR Rhodes Pharmaceuticals

LP3

Not available

locally

METADATE

CD

UCB Inc.3

RITALIN LA Novartis Pharmaceuticals

Corp.3

15mg Extended-

Release Capsule

APTENSIO XR Rhodes Pharmaceuticals

LP3

Not available

locally

20 mg Modified-

Release Capsule

RITALIN LA Novartis Healthcare Phils.,

Inc. [Alkermes Gainesville

LLC – USA]

DR-XY43804

30 mg Modified-

Release Capsule

RITALIN LA Novartis Healthcare Phils.,

Inc. [Alkermes Gainesville

LLC – USA]

DR-XY43805

40 mg Modified-

Release Capsule

RITALIN LA Novartis Healthcare Phils.,

Inc. [Alkermes Gainesville

LLC – USA]

DR-XY43806

50mg Extended-

Release Capsule

APTENSIO XR Rhodes Pharmaceuticals

LP3

Not available

locally

METADATE

CD

UCB Inc.3

60mg Extended-

Release Capsule

APTENSIO XR Rhodes Pharmaceuticals

LP3

Not available

locally

METADATE

CD

UCB Inc.3

5mg/mL Powder

for Extended-

Release Oral

Suspension

QUILLIVANT

XR

Nextwave Pharmaceuticals

Inc.3

Not available

locally

Methylprednisolone 2mg Tablet MEDRONE Pfizer Limited2 Not available

locally MEDROL Pharmacia and Upjohn

Co.3

4mg Tablet MEDROL Pfizer Inc. [Pfizer Italia

S.r.l. – Italy]

DRP-3440

8mg Tablet MEDROL Pharmacia and Upjohn

Co.3

Not available

locally

16mg Tablet MEDROL Pfizer Inc. [Pfizer Italia

S.r.l. – Italy]

DRP-3441

32mg Tablet MEDROL Pharmacia and Upjohn

Co.3

Not available

locally

Metoclopramide (as

Hydrochloride)

5mg Tablet PRIMPERAN Sanofi2 Not available

locally REGLAN Ani Pharmaceuticals Inc.3

10mg Tablet PLASIL Sanofi-Aventis Phils., Inc.

[Sanofi-Aventis S.p.A. –

Italy]

DR-950

Page 82:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

82

Metoprolol succinate 23.75mg

(equivalent to

25mg Metoprolol

Tartrate)

Controlled-Release

Tablet

BETAZOK AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca AB –

Sweden]

DR-XY29023

47.5mg

(equivalent to

50mg Metoprolol

Tartrate)

Extended-

/Controlled-

Release Tablet

BELOC-ZOK/

SELO-ZOK

AstraZeneca2 Not available

locally

TOPROL-XL Aralez Pharmaceuticals

Trading DAC3

95mg (equivalent

to 100mg

Metoprolol

Tartrate)

Controlled-Release

Tablet

BETAZOK AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca AB –

Sweden]

DR-XY12973

190mg (equivalent

to 200mg

Metoprolol

Tartrate)

Controlled-Release

Tablet

BELOC-ZOK/

SELO-ZOK

AstraZeneca2 Not available

locally

TOPROL-XL Aralez Pharmaceuticals

Trading DAC3

Metoprolol succinate

+

Hydrochlorothiazide

23.75mg

(equivalent to

25mg Metoprolol

Tartrate)/12.5mg

Extended-Release

Tablet

DUTOPROL Concordia Pharmaceuticals

Inc.3

Not available

locally

47.5mg

(equivalent to

50mg Metoprolol

Tartrate)/12.5mg

Extended-Release

Tablet

DUTOPROL Concordia Pharmaceuticals

Inc.3

Not available

locally

95mg (equivalent

to 100mg

Metoprolol

Tartrate)/12.5mg

Extended-Release

Tablet

DUTOPROL Concordia Pharmaceuticals

Inc.3

Not available

locally

Metoprolol tartrate 50mg Tablet BETALOC AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca

Pharmaceutical Co. Ltd. –

China]

DR-X1848

Page 83:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

83

100mg Tablet BETALOC AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca

Pharmaceutical Co. Ltd. –

China]

DR-X1812

Metoprolol tartrate +

Hydrochlorothiazide

50mg/25mg Tablet LOPRESSOR

HCT

US Pharmaceuticals

Holdings I LLC3

Not available

locally

100mg/25mg

Tablet

LOPRESSOR

HCT

US Pharmaceuticals

Holdings I LLC3

Not available

locally

Metronidazole (as

Benzoate)

25mg/mL (125

mg/5mL) Oral

Suspension

FLAGYL Sanofi-Aventis Phils., Inc.

[PT. Boehringer Ingelheim

– Indonesia/PT. Aventis

Pharma – Indonesia]

DR-9040

Metronidazole 200mg Tablet FLAGYL Zentiva2 Not available

locally

250mg Tablet FLAGYL GD Searle LLC3 Not available

locally

400mg Tablet FLAGYL Zentiva2 Not available

locally

500 mg Tablet FLAGYL

FORTE

Sanofi-Aventis Phils., Inc.

[PT. Aventis Pharma –

Indonesia]

DRP-009

750mg Extended-

Release Tablet

FLAGYL GD Searle LLC3 Not available

locally

375mg Capsule FLAGYL GD Searle LLC3 Not available

locally

Midazolam (as

Maleate)

7.5mg Tablet DORMICUM Roche2, 3 Not available

locally

15mg Tablet DORMICUM Roche (Philippines), Inc.

[Productos Roche S.A. de

C.V. – Mexico]

DR-XY41657

Roche (Philippines), Inc.

[F. Hoffmann-La Roche

Ltd. – Switzerland]

DR-XY3516

Minocycline (as

hydrochloride)

50mg Capsule MINOCIN Pfizer, Inc. [Interphil

Labs., Inc.]

DR-X1186

100 mg Capsule MINOCIN Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-3375

100mg Modified-

Release Capsule

MINOCIN Meda Pharmaceuticals2 Not available

locally

55mg Extended-

Release Tablet

SOLODYN Medicris Pharmaceutical

Corp.3

Not available

locally

65mg Extended-

Release Tablet

SOLODYN Medicris Pharmaceutical

Corp.3

Not available

locally

80mg Extended-

Release Tablet

SOLODYN Medicris Pharmaceutical

Corp.3

Not available

locally

Page 84:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

84

105mg Extended-

Release Tablet

SOLODYN Medicris Pharmaceutical

Corp.3

Not available

locally

115mg Extended-

Release Tablet

SOLODYN Medicris Pharmaceutical

Corp.3

Not available

locally

Mirtazapine 15 mg

Orodispersible

Tablet

REMERON

SOLTAB

Merck Sharp & Dohme

(I.A.) Corp. [Cephalon,

Inc. – USA]

DR-XY29233

30 mg

Orodispersible

Tablet

REMERON

SOLTAB

Merck Sharp & Dohme

(I.A.) Corp. [Cephalon,

Inc. – USA]

DR-XY29236

45 mg

Orodispersible

Tablet

REMERON

SOLTAB

Merck Sharp & Dohme

(I.A.) Corp. [Cephalon,

Inc. – USA]

DR-XY29235

15 mg Tablet REMERON N.V. Organon –

Netherlands2

Not Available

Locally

Organon USA Inc.3

30 mg Tablet REMERON N.V. Organon –

Netherlands2

Not Available

Locally

Organon USA Inc.3

45 mg Tablet REMERON N.V. Organon –

Netherlands2

Not Available

Locally

Organon USA Inc.3

Modafinil 100mg Tablet PROVIGIL Cepahlon UK

Limited/Teva Pharma

B.V.2

Not Available

Locally

Cephalon Inc.3

200mg Tablet PROVIGIL Cepahlon UK

Limited/Teva Pharma

B.V.2

Not Available

Locally

Cephalon Inc.3

Montelukast (as

sodium)

4 mg Chewable

Tablet

SINGULAIR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-6234

(DR-XY27122)

5 mg Chewable

Tablet

SINGULAIR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-6233

(DR-XY24156)

10 mg Film-

Coated Tablet

SINGULAIR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DR-XY24157

4 mg Oral

Granules

SINGULAIR Merck Sharp & Dohme

(I.A.) Corp. [DSM

Pharm’ls Inc. – USA]

DRP-6235

(DR-XY43566)

Page 85:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

85

Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Corp. – USA]

DR-XY28982

Morphine sulfate 5mg Prolonged-

/Extended-Release

Tablet

MST

CONTINUS

Napp Pharmaceuticals

Limited2

Not available

locally

10 mg Modified-

Release Tablet

MST

CONTINUS

Mundipharma Distribution

GmbH (Phil. Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY13020

15mg Prolonged-

/Extended-Release

Tablet

MST

CONTINUS

Napp Pharmaceuticals

Limited2

Not available

locally

ARYMO ER Egalet Corp.3

MORPHABON

D ER

Daiichi Sankyo Inc.3

MS CONTIN Purdue Pharma LP3

30 mg Modified-

Release Tablet

MST

CONTINUS Mundipharma Distribution

GmbH (Phil. Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY13019

60 mg Modified-

Release Tablet

MST

CONTINUS Mundipharma Distribution

GmbH (Phil. Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY13021

100 mg Modified-

Release Tablet

MST

CONTINUS Mundipharma Distribution

GmbH (Phil. Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY13022

200mg Prolonged-

/Extended-Release

Tablet

MST

CONTINUS

Napp Pharmaceuticals

Limited2

Not available

locally

MS CONTIN Purdue Pharma LP3

15mg Tablet MORPHINE

SULFATE

West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

30mg Tablet MORPHINE

SULFATE

West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

10mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

20mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

30mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

40mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

50mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

Page 86:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

86

60mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

70mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

80mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

100mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

130mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

150mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

200mg Extended-

Release Capsule

KADIAN Allergan Sales LLC3 Not available

locally

Moxifloxacin (as

hydrochloride)

400 mg Tablet AVELOX Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY25608

Mycophenolate

mofetil

250 mg Capsule CELLCEPT Roche Products Limited2 Not available

locally Roche Palo Alto LLC3

500 mg Tablet CELLCEPT Roche Products Limited2 Not available

locally Roche Palo Alto LLC3

180mg Delayed-

Release (Gastro-

Resistant) Tablet

MYFORTIC Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

Novartis Pharmaceuticals

Corp.3

360mg Delayed-

Release (Gastro-

Resistant) Tablet

MYFORTIC Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY28874

200mg/mL

(Powder for) Oral

Suspension

CELLCEPT Roche Products Limited2 Not available

locally Roche Palo Alto LLC3

Naproxen 250 mg Tablet NAPROSYN

LLE

Roche (Phils.), Inc. [Roche

Farma S.A. – Spain]

DR-XY16667

375mg Tablet NAPROSYN Atnahs Pharma US Ltd.3 Not available

locally

500 mg Tablet NAPROSYN

LLE FORTE

Roche (Phils.), Inc. [Roche

Farma S.A. – Spain]

DR-XY16668

375mg Delayed-

Release Tablet

EC-

NAPROSYN

Atnahs Pharma US Ltd.3 Not available

locally

500 mg Delayed-

Release Tablet

EC-

NAPROSYN

Atnahs Pharma US Ltd.3 Not available

locally

25mg/mL Oral

Suspension

NAPROSYN Atnahs Pharma US Ltd.3 Not available

locally

Naproxen sodium 220mg (equivalent

to 200mg

Naproxen) Tablet

ALEVE Bayer2 Not available

locally Bayer Healthcare LLC3

Page 87:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

87

275 mg Tablet FLANAX Roche (Phils.), Inc.

[Interphil Labs., Inc.]

DR-X7096

550 mg Tablet FLANAX

FORTE

Roche (Phils.), Inc.

[Interphil Labs., Inc.]

DR-XY2914

412.5mg

(equivalent to

375mg Naproxen)

Extended-Release

Tablet

NAPRELAN Alvogen Malta Operations

Ltd.3

Not available

locally

550mg (equivalent

to 500mg

Naproxen)

Extended-Release

Tablet

NAPRELAN Alvogen Malta Operations

Ltd.3

Not available

locally

825mg (equivalent

to 750mg

Naproxen)

Extended-Release

Tablet

NAPRELAN Alvogen Malta Operations

Ltd.3

Not available

locally

Nateglinide 60mg Tablet STARLIX Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

Novartis Pharmaceuticals

Corp.3

120mg Tablet STARLIX Novartis Healthcare

Philippines, Inc. [Novartis

Farma S.p.A – Italy]

DR-XY26817

180mg Tablet STARLIX Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

Nebivolol (as

hydrochloride)

2.5 mg Tablet NEBICAR OEP Phils., Inc. [Micro

Labs Ltd. – India]

DR-XY36295

BYSTOLIC Allergan Sales LLC3 Not available

locally

5 mg Tablet NEBICAR OEP Phils., Inc. [Micro

Labs Ltd. – India]

DR-XY31941

NEBILET A. Menarini Phils., Inc.

[Berlin-Chemie AG –

Germany]

DR-XY36223

LOBIVON Transfarma Phils., Inc.

[Berlin-Chemie AG –

Germany]

DR-XY36226

BYSTOLIC Allergan Sales LLC3 Not available

locally

10mg Tablet BYSTOLIC Allergan Sales LLC3 Not available

locally

20mg Tablet BYSTOLIC Allergan Sales LLC3 Not available

locally

Page 88:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

88

Nebivolol (as

hydrochloride) +

Valsartan

5mg/80mg Tablet BYVALSON Allergan Sales LLC3 Not available

locally

Netupitant +

Palonosetron (as

Hydrochloride)

300mg/500mcg

Capsule

AKYNZEO Mundipharma Distribution

GmbH (Philippine Branch)

[Helsinn Healthcare SA –

Ireland]

DR-XY45947

Nevirapine 200mg Tablet VIRAMUNE Boehringer Ingelheim

Limited2

Not available

locally

Boehringer Ingelheim

Pharmaceuticals Inc.3

100mg Prolonged-

/Extended-Release

Tablet

VIRAMUNE Boehringer Ingelheim

Limited2

Not available

locally

Boehringer Ingelheim

Pharmaceuticals Inc.3

400mg Prolonged-

/Extended-Release

Tablet

VIRAMUNE Boehringer Ingelheim

Limited2

Not available

locally

Boehringer Ingelheim

Pharmaceuticals Inc.3

50mg/5mL Oral

Suspension

VIRAMUNE Boehringer Ingelheim

Limited2

Not available

locally

Boehringer Ingelheim

Pharmaceuticals Inc.3

Nifedipine 5mg Capsule ADALAT Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DRP-639

10mg Capsule ADALAT Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DRP-618

10mg Modified-

Release Tablet

ADALAT

RETARD

Bayer plc2 Not available

locally

20mg Tablet ADALAT

RETARD

Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DR-XY455

20mg Prolonged-

Release Tablet

ADALAT GITS

20

Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DR-XY25315

30mg Prolonged-

Release Tablet

ADALAT GITS

30

Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DR-XY26959

60mg Prolonged-

Release Tablet

ADALAT GITS

60

Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DR-XY27180

90mg Prolonged-

/Extended-Release

Tablet

ADALAT CC Alvogen Group Holdings

LLC3

Not available

locally

PROCARDIA

XL

Pfizer Laboratories Div.

Pfizer Inc.3

Page 89:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

89

Nifuroxazide 200mg Capsule ERCEFURYL Sanofi-Aventis Philippines,

Inc. [Sanofi Winthrop

Industrie – France]

DR-XY32655

Nilotinib (as

Hydrochloride)

150mg Capsule TASIGNA Novartis Healthcare

Philippines Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY41226

200mg Capsule TASIGNA Novartis Healthcare

Philippines Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY34278

Nimodipine 30mg Tablet NIMOTOP Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DR-XY35004

Nintedanib (as

Esilate)

100mg Capsule OFEV Boehringer Ingelheim

(Phils.) Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45611

150mg Capsule OFEV Boehringer Ingelheim

(Phils.) Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY45610

Nitrofurantoin 25mg Capsule MACRODANTI

N

Alvogen Malta Operations

Ltd.3

Not available

locally

50 mg Capsule MACRODANTI

N

Boehringer Ingelheim

(Phils.), Inc. [Boehringer

Ingelheim Promeco, S.A.

de C.V. – Mexico

DR-X1085

100 mg Capsule MACRODANTI

N

Boehringer Ingelheim

(Phils.), Inc. [Boehringer

Ingelheim Promeco, S.A.

de C.V. – Mexico

DR-X1086

URITRACIN Biofemme, Inc. [Amherst

Labs., Inc.]

DR-XY36232

Unbranded Pharex Health Corp.

[Pascual Labs., Inc.]

DR-XY18341

200 mg Tablet Unbranded Pharex Health Corp.

[Pascual Labs., Inc.]

DR-XY18340

Norfloxacin 200mg Tablet Unbranded Pharex Health Corp.

[Pascual Labs., Inc.]

DR-XY18340

400mg Tablet Unbranded Pharex Health Corp.

[Pascual Labs., Inc.]

DR-XY18341

URITRACIN Biofemme, Inc. [Amherst

Labs., Inc.]

DR-XY36232

Nystatin 500000 Units

Tablet

NYSTATIN Teva Pharmaceuticals USA

Inc.3

Not available

locally

Page 90:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

90

100000 Units/mL

Oral Suspension

NYSTATINE

LABAZ

Sanofi-Aventis2 Not available

locally

MYCOSTATIN Bristol-Myers Squibb2

NYSTATIN Wockhardt EU Operations

(Swiss) AG3

Olanzapine 2.5mg Tablet ZYPREXA Eli Lilly and Company

Limited2

Not available

locally

Eli Lilly and Co.3

5 mg Tablet ZYPREXA Eli Lilly [Lilly del Caribe,

Inc. – Puerto Rico]

DR-XY22855

7.5mg Tablet ZYPREXA Eli Lilly and Company

Limited2

Not available

locally

Eli Lilly and Co.3

10 mg Tablet ZYPREXA Eli Lilly [Lilly del Caribe,

Inc. – Puerto Rico]

DR-XY22856

15mg Tablet ZYPREXA Eli Lilly and Company

Limited2

Not available

locally

Eli Lilly and Co.3

20mg Tablet ZYPREXA Eli Lilly and Company

Limited2

Not available

locally

Eli Lilly and Co.3

5 mg

Orodispersible

Tablet

ZYPREXA

ZYDIS

Eli Lilly [Catalent UK

Swindon Zydis Ltd. –

United Kingdom]

DR-XY37273

10 mg

Orodispersible

Tablet

ZYPREXA

ZYDIS

Eli Lilly [Catalent UK

Swindon Zydis Ltd. –

United Kingdom]

DR-XY37455

15mg

Orodispersible

Tablet

ZYPREXA

VELOTAB

Eli Lilly and Company

Limited2

Not available

locally

ZYPREXA

ZYDIS

Eli Lilly and Co.3

20mg

Orodispersible

Tablet

ZYPREXA

VELOTAB

Eli Lilly and Company

Limited2

Not available

locally

ZYPREXA

ZYDIS

Eli Lilly and Co.3

Olmesartan

medoxomil

5mg Tablet BENICAR Daiichi Sankyo Inc.3 Not available

locally

10 mg Tablet OLMETEC Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DRP-3449

(DR-XY29916)

20 mg Tablet OLMETEC Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DRP-3448

(DR-XY22915)

40 mg Tablet OLMETEC Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DRP-3450

(DR-XY29914)

Page 91:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

91

Olmesartan

medoxomil +

Hydrochlorothiazide

20 mg/12.5 mg

Tablet

OLMETEC

PLUS

Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DR-XY31571

20mg/25mg Tablet OLMETEC

PLUS

Daiichi Sankyo UK

Limited2

Not available

locally

40 mg/12.5 mg

Tablet

OLMETEC

PLUS

Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DR-XY32003

40 mg/25 mg

Tablet

OLMETEC

PLUS

Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DR-XY32002

Omeprazole 10 mg Delayed-

Release Capsule

LOSEC AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

AB – Sweden]

DR-XY18046

20 mg Delayed-

Release Capsule

LOSEC AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

AB – Sweden]

DR-XY18227

40 mg Delayed-

Release Capsule

LOSEC AstraZeneca UK Limited2 Not available

locally

Omeprazole (as

magnesium)

10mg Delayed-

Release Tablet

LOSEC MUPS AstraZeneca UK Limited2 Not available

locally

20mg Delayed-

Release Tablet

LOSEC MUPS AstraZeneca UK Limited2 Not available

locally PRILOSEC AstraZeneca

Pharmaceuticals LP3

40mg Delayed-

Release Tablet

LOSEC MUPS AstraZeneca UK Limited2 Not available

locally

2.5mg Powder for

Delayed-Release

Oral Suspension

PRILOSEC Covis Pharma BV3 Not available

locally

10mg Powder for

Delayed-Release

Oral Suspension

PRILOSEC Covis Pharma BV3 Not available

locally

Omeprazole +

Sodium Bicarbonate

20mg/1.1g

Capsule

ZEGERID Santarus Inc.3 Not available

locally

40mg/1.1g

Capsule

ZEGERID Santarus Inc.3 Not available

locally

20mg/1.68g

Powder for Oral

Suspension

ZEGERID Santarus Inc.3 Not available

locally

40mg/1.68g

Powder for Oral

Suspension

ZEGERID Santarus Inc.3 Not available

locally

Ondansetron (as

hydrochloride)

4 mg Tablet ZOFRAN Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

Novartis Pharmaceuticals

Corp.3

Page 92:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

92

8 mg Tablet ZOFRAN GlaxoSmithKline

Philippines, Inc. [Aspen

Bad Oldesloe GmbH –

Germany]

DR-XY13371

24mg Tablet ZOFRAN Novartis Pharmaceuticals

Corp.3

Not available

locally

4mg Orally

Disintegrating

Tablet

ZOFRAN

(ZYDIS/MELT)

Glaxo Wellcome/Novartis

Pharmaceuticals UK Ltd. 2

Not available

locally

ZOFRAN ODT Novartis Pharmaceuticals

Corp.3

8mg Orally

Disintegrating

Tablet

ZOFRAN

(ZYDIS/MELT)

Glaxo Wellcome/Novartis

Pharmaceuticals UK Ltd. 2

Not available

locally

ZOFRAN ODT Novartis Pharmaceuticals

Corp.3

Orlistat 120mg Capsule XENICAL Roche Philippines, Inc.

[Roche S.p.A. – Italy]

DRP-527

Orphenadrine citrate

+ Paracetamol

35 mg/450 mg

Tablet

NORGESIC Metro Drug, Inc. [iNova

Pharm’ls Australia) Pty.

Ltd. – Australia]

DR-1123

50 mg/650 mg

Tablet

NORGESIC

FORTE

Metro Drug, Inc. [iNova

Pharm’ls Australia) Pty.

Ltd. – Australia]

DR-XY4115

Oseltamivir (as

Phosphate)

30mg Capsule TAMIFLU Roche Philippines, Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY36386

Roche Philippines, Inc.

[Roche S.p.A. – Italy]

DR-XY40611

45mg Capsule TAMIFLU Roche Philippines, Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY36385

Roche Philippines, Inc.

[Roche S.p.A. – Italy]

DR-XY40613

75mg Capsule TAMIFLU Roche Philippines, Inc.

[Catalent Germany

Schormdorf GmbH –

Germany]

DR-XY37538

Roche Philippines, Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY26137

Roche Philippines, Inc.

[Cenexi S.A.S. – France]

DR-XY34215

Roche Philippines, Inc.

[Roche S.p.A. – Italy]

DR-XY40612

6mg/mL Powder

for Oral

Suspension

TAMIFLU Roche Philippines, Inc.

[Rottendorf Pharma GmbH

– Germany]

DR-XY43627

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93

12mg/mL Powder

for Oral

Suspension

TAMIFLU Roche2,3 Not available

locally

Oxcarbazepine 150mg Tablet TRILEPTAL Novartis Pharmaceuticals

UK Ltd.2

Not available

locally

Novartis Pharmaceuticals

Corp.3

300 mg Tablet TRILEPTAL Novartis Healthcare Phils.,

Inc. [Novartis Farma

S.p.A. – Italy]

DR-XY22095

600 mg Tablet TRILEPTAL Novartis Healthcare Phils.,

Inc. [Novartis Farma

S.p.A. – Italy]

DR-XY36562

60 mg/mL Oral

Suspension

TRILEPTAL Novartis Healthcare Phils.,

Inc. [Novartis Pharma S.A.

– France]

DR-XY27599

150mg Extended-

Release Tablet

OXTELLAR XR Supernus Pharmaceuticals

Inc.3

Not available

locally

300mg Extended-

Release Tablet

OXTELLAR XR Supernus Pharmaceuticals

Inc.3

Not available

locally

600mg Extended-

Release Tablet

OXTELLAR XR Supernus Pharmaceuticals

Inc.3

Not available

locally

Oxybutynin

Hydrochloride

2.5mg Tablet DITROPAN Sanofi2 Not available

locally

5mg Tablet DRIPTANE Abbott Products Phils. Inc.

[Recipharm Fontaine –

France]

DR-XY24315

5mg Extended-

/Prolonged-

Release Tablet

LYRINEL XL Janssen-Cilag Ltd.2 Not available

locally DITROPAN XL Janssen Pharmaceuticals

Inc.3

10mg Prolonged-/

Extended-Release

Tablet

LYRINEL XL Janssen-Cilag Ltd.2 Not available

locally DITROPAN XL Janssen Pharmaceuticals

Inc.3

15mg Prolonged-

Release Tablet

DITROPAN XL Janssen Pharmaceuticals

Inc.3

Not available

locally

Oxycodone 9mg Extended-

Release Capsule

XTAMPZA ER Collegium International

Inc.3

Not available

locally

13.5mg Extended-

Release Capsule

XTAMPZA ER Collegium International

Inc.3

Not available

locally

18mg Extended-

Release Capsule

XTAMPZA ER Collegium International

Inc.3

Not available

locally

27mg Extended-

Release Capsule

XTAMPZA ER Collegium International

Inc.3

Not available

locally

36mg Extended-

Release Capsule

XTAMPZA ER Collegium International

Inc.3

Not available

locally

Oxycodone

hydrochloride

5 mg Prolonged-

Release Tablet

OXYCONTIN Mundipharma Distribution

GmbH (Philippine Branch)

DR-XY31372

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94

[Bard Pharm’ls Ltd. –

United Kingdom]

10 mg Prolonged-

/Controlled-

Release Tablet

OXYCONTIN Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY27751

OXYCONTIN

NEO

Mundipharma Distribution

GmbH (Philippine Branch)

[Purdue Pharmaceuticals

LP – USA]

DR-XY45704

15mg Controlled-

Release Tablet

OXYCONTIN

NEO

Mundipharma Distribution

GmbH (Philippine Branch)

[Purdue Pharmaceuticals

LP – USA]

DR-XY45705

20 mg Prolonged-

/Controlled-

Release Tablet

OXYCONTIN Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY27748

OXYCONTIN

NEO

Mundipharma Distribution

GmbH (Philippine Branch)

[Purdue Pharmaceuticals

LP – USA]

DR-XY45706

30mg Controlled-

Release Tablet

OXYCONTIN

NEO

Mundipharma Distribution

GmbH (Philippine Branch)

[Purdue Pharmaceuticals

LP – USA]

DR-XY45707

40 mg Prolonged-

/Controlled-

Release Tablet

OXYCONTIN Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY27750

OXYCONTIN

NEO

Mundipharma Distribution

GmbH (Philippine Branch)

[Purdue Pharmaceuticals

LP – USA]

DR-XY45708

60mg Controlled-

Release Tablet

OXYCONTIN

NEO

Mundipharma Distribution

GmbH (Philippine Branch)

[Purdue Pharmaceuticals

LP – USA]

DR-XY45709

80 mg Prolonged-

/Controlled-

Release Tablet

OXYCONTIN Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY27749

OXYCONTIN Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY40279

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95

OXYCONTIN

NEO

Mundipharma Distribution

GmbH (Philippine Branch)

[Purdue Pharmaceuticals

LP – USA]

DR-XY45710

120mg Prolonged-

Release Tablet

OXYCONTIN Napp Pharmaceuticals

Limited2

Not available

locally

5 mg Capsule OXYNORM Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY32009

10 mg Capsule OXYNORM Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY32011

20 mg Capsule OXYNORM Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY32010

5mg Tablet ROXICODONE Mallinckrodt Inc.3 Not available

locally

15mg Tablet ROXICODONE Mallinckrodt Inc.3 Not available

locally

30mg Tablet ROXICODONE Mallinckrodt Inc.3 Not available

locally

Oxycodone

hydrochloride +

Naloxone

hydrochloride

5mg/2.5mg

Prolonged-Release

Tablet

TARGINACT Napp Pharmaceuticals

Limited2

Not available

locally

10 mg/5 mg

Prolonged-Release

Tablet

TARGIN Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY40703

20 mg/10 mg

Prolonged-Release

Tablet

TARGIN Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY40700

40 mg/20 mg

Prolonged-Release

Tablet

TARGIN Mundipharma Distribution

GmbH (Philippine Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY40702

Paliperidone 1.5mg Extended-

Release Tablet

INVEGA Janssen-Cilag Ltd.2 Not available

locally Janssen Pharmaceuticals

Inc.3

3mg Extended-

Release Tablet

INVEGA Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

Manufacturing LLC –

Puerto Rico]

DR-XY33919

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96

6mg Extended-

Release Tablet

INVEGA Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

Manufacturing LLC –

Puerto Rico]

DR-XY33920

9mg Extended-

Release Tablet

INVEGA Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

Manufacturing LLC –

Puerto Rico]

DR-XY33921

Palonosetron (as

Hydrochloride)

500mcg Capsule ALOXI Mundipharma Distribution

GmbH (Philippine Branch)

[Catalent Pharma Solution

– USA]

DR-XY45629

Pantoprazole (as

sodium)

20 mg Enteric-

Coated Tablet

ULCEPRAZ Isopharma, Inc. [Nycomed

GmbH – Germany]

DR-XY26492

PANTOLOC Takeda Healthcare Phils.,

Inc. [Takeda GmbH –

Germany]

DR-XY28439

40 mg Enteric-

Coated Tablet

ULCEPRAZ Isopharma, Inc. [Nycomed

GmbH – Germany]

DR-XY22309

PANTOLOC Takeda Healthcare Phils.,

Inc. [Takeda GmbH –

Germany]

DR-XY28438

Paracetamol 120 mg Chewable

Tablet

KIDDILETS United Home Products

[United Laboratories, Inc.]

DRHR-1160

325 mg Tablet TEMPRA Taisho Pharm’ls Phils.,

Inc. [Interphil Labs., Inc.]

DR-4396

500 mg Tablet BIOGESIC Biomedis, Inc. [United

Laboratories, Inc.]

DR-153

BIOGESIC Biomedis, Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY39670

500 mg Capsule ACETADOL Medi-Rx, Inc. DR-XY9311

100 mg/mL Oral

Suspension

(Drops)

BIOGESIC

(Orange Flavor)

Biomedis, Inc. [Amherst

Labs., Inc.]

DRHR-1167

BIOGESIC

(Orange Flavor)

Biomedis, Inc. [United

Labs., Inc.]

DR-XY39532

CALPOL GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham]

DRHR-1399

CALPOL GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham]

DR-XY19170

NAPREX

(Melon Flavor)

Pediatrica, Inc. [Amherst

Labs., Inc.]

DRHR-1292

120 mg/5 mL Oral

Suspension

BIOGESIC

(Orange Flavor)

Biomedis, Inc. [Amherst

Labs., Inc.]

DRHR-637

BIOGESIC

(Orange Flavor)

Biomedis, Inc. [United

Labs., Inc.]

DRHR-1443

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97

BIOGESIC

(Strawberry

Flavor)

Biomedis, Inc. [Amherst

Labs., Inc.]

DRHR-638

BIOGESIC

(Strawberry

Flavor)

Biomedis, Inc. [United

Labs., Inc.]

DRHR-1444

CALPOL

(Strawberry

Flavor)

GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham]

DRHR-495

NAPREX

(Melon Flavor)

Pediatrica, Inc. [Amherst

Labs., Inc.]

DRHR-699

250 mg/5 mL Oral

Suspension

BIOGESIC

(Orange Flavor)

Biomedis, Inc. [Amherst

Labs., Inc.]

DR-XY27612

BIOGESIC

(Orange Flavor)

Biomedis, Inc. [United

Labs., Inc.]

DR-XY39533

BIOGESIC

(Strawberry

Flavor)

Biomedis, Inc. [Amherst

Labs., Inc.]

DR-XY27550

BIOGESIC

(Strawberry

Flavor)

Biomedis, Inc. [United

Labs., Inc.]

DR-XY39531

CALPOL

(Orange Flavor)

GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham]

DRHR-913

NAPREX

(Melon Flavor)

Pediatrica, Inc. [Amherst

Labs., Inc.]

DR-XY27607

Paroxetine (as

Hydrochloride)

10mg Tablet SEROXAT GlaxoSmithKline UK2 Not available

locally PAXIL Apotex Technologies Inc.3

20 mg Tablet SEROXAT GlaxoSmithKline Phils.,

Inc. [S.C. Europharm S.A.

– Romania/

GlaxoSmithKline

Pharmaceuticals SA –

Poland]

DR-XY16055

30mg Tablet SEROXAT GlaxoSmithKline UK2 Not available

locally PAXIL Apotex Technologies Inc.3

40mg Tablet PAXIL Apotex Technologies Inc.3 Not available

locally

10mg/5mL

(20mg/10mL) Oral

Suspension

SEROXAT GlaxoSmithKline UK2 Not available

locally PAXIL Apotex Technologies Inc.3

12.5mg Extended-

Release Tablet

PAXIL CR Apotex Technologies Inc.3 Not available

locally

25mg Extended-

Release Tablet

PAXIL CR Apotex Technologies Inc.3 Not available

locally

37.5mg Extended-

Release Tablet

PAXIL CR Apotex Technologies Inc.3 Not available

locally

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98

Paroxetine (as

Mesilate)

7.5mg Capsule BRISDELLE Sebela Ireland Ltd.3 Not available

locally

10mg Tablet PEXEVA Sebela Ireland Ltd.3 Not available

locally

20mg Tablet PEXEVA Sebela Ireland Ltd.3 Not available

locally

30mg Tablet PEXEVA Sebela Ireland Ltd.3 Not available

locally

40mg Tablet PEXEVA Sebela Ireland Ltd.3 Not available

locally

Pazopanib (as

Hydrochloride)

200mg Tablet VOTRIENT GlaxoSmithKline

Philippines Inc. [Glaxo

Operations UK Limited –

United Kingdom]

DR-XY39926

400mg Tablet VOTRIENT GlaxoSmithKline

Philippines Inc. [Glaxo

Operations UK Limited –

United Kingdom]

DR-XY39925

Pentoxifylline 400mg Sustained-

Release Tablet

TRENTAL Sanofi-Aventis Philippines,

Inc. [PT Aventis Pharma –

Indonesia]

DR-XY25115

Perampanel 2mg Tablet FYCOMPA Hi-Eisai Pharmaceutical,

Inc. [Eisai Manufacturing

Ltd. – United Kingdom]

DR-XY44353

4mg Tablet FYCOMPA Hi-Eisai Pharmaceutical,

Inc. [Eisai Manufacturing

Ltd. – United Kingdom]

DR-XY44354

6mg Tablet FYCOMPA Hi-Eisai Pharmaceutical,

Inc. [Eisai Manufacturing

Ltd. – United Kingdom]

DR-XY44355

8mg Tablet FYCOMPA Hi-Eisai Pharmaceutical,

Inc. [Eisai Manufacturing

Ltd. – United Kingdom]

DR-XY44410

10mg Tablet FYCOMPA Hi-Eisai Pharmaceutical,

Inc. [Eisai Manufacturing

Ltd. – United Kingdom]

DR-XY44361

12mg Tablet FYCOMPA Hi-Eisai Pharmaceutical,

Inc. [Eisai Manufacturing

Ltd. – United Kingdom]

DR-XY44356

500mcg/mL Oral

Suspension

FYCOMPA Eisai Inc.3 Not available

locally

Perindopril arginine 5 mg Tablet COVERSYL Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY34344

10 mg Tablet COVERSYL Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY34345

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99

Perindopril arginine +

Amlodipine (as

besilate)

3.5 mg/2.5 mg

Tablet

VIACORAM

INITIO

Servier Phils., Inc. [Servier

(Ireland) Industries –

Ireland]]

DR-XY45452

7 mg/5 mg

Tablet

COVERAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]]

DR-XY45453

14mg/10mg Tablet PRESTALIA Symplmed

Pharmaceuticals LLC3

Not available

locally

5 mg/5 mg

Tablet

COVERAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]]

DR-XY36009

5 mg/10 mg Tablet COVERAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]]

DR-XY36010

10 mg/5 mg Tablet COVERAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]]

DR-XY36011

10 mg/10 mg

Tablet

COVERAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]]

DR-XY36012

Perindopril arginine +

Indapamide

2 mg/625 mcg

Tablet

PRETERAX Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY24876

4 mg/1.25 mg

Tablet

BI-PRETERAX Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY24877

5 mg/1.25 mg

Tablet

COVERSYL

PLUS

Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY34792

10 mg/2.5 mg

Tablet

COVERSYL

PLUS

Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]

DR-XY38472

Perindopril arginine +

Indapamide +

Amlodipine (as

besilate)

2.5 mg/625 mcg/5

mg Tablet

TRIPLIXAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]

DR-XY44975

5 mg/1.25 mg/5

mg Tablet

TRIPLIXAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]

DR-XY44976

5 mg/1.25 mg/10

mg Tablet

TRIPLIXAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]

DR-XY44977

10 mg/2.5 mg/5

mg Tablet

TRIPLIXAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]

DR-XY44978

10 mg/2.5 mg/10

mg Tablet

TRIPLIXAM Servier Phils., Inc. [Servier

(Ireland) Industries Ltd. –

Ireland]

DR-XY44979

Page 100:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

100

Perindopril erbumine 2mg Tablet PERINDOPRIL

ERBUMINE

Aurobindo Pharma Ltd.3 Not available

locally

ACEON Symplimed

Pharmaceuticals LLC3

4mg Tablet PERINDOPRIL

ERBUMINE

Aurobindo Pharma Ltd.3 Not available

locally

ACEON Symplimed

Pharmaceuticals LLC3

8mg Tablet PERINDOPRIL

ERBUMINE

Aurobindo Pharma Ltd.3 Not available

locally

ACEON Symplimed

Pharmaceuticals LLC3

Phenobarbital 15 mg Tablet

Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-X1824

30 mg Tablet

Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-5064

60 mg Tablet

Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-X2017

90 mg Tablet

Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-XY21882

Phenylephrine

hydrochloride +

Paracetamol

10 mg/500 mg

Tablet

NO-DROWSE

DECOLGEN

Westmont Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY29288

NO-DROWSE

DECOLGEN

Westmont Pharm’ls, Inc.

[PT. Medifarma Labs. –

Indonesia]

DR-XY42877

NEOZEP NON-

DROWSY

Myra Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY30216

NEOZEP NON-

DROWSY

Myra Pharm’ls, Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY42978

Phenylephrine

hydrochloride +

Dextromethorphan

hydrobromide +

Paracetamol

10 mg/15mg/325

mg Capsule

TUSERAN

FORTE

Medichem Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY29720

TUSERAN

FORTE

Medichem Pharm’ls, Inc.

[PT. Medifarma Labs. –

Indonesia]

DR-XY41123

Phenylpropanolamine

hydrochloride +

Paracetamol

18 mg/325 mg

Capsule

ORNEX GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

(Phils.)]

DR-9189

25 mg/325 mg

Capsule

NASATHERA Morishita-Seggs Pharm’ls,

Inc. [Morishita-Seggs

Pharm’ls, Inc.]

DR-XY4383

Phenylpropanolamine

hydrochloride +

Dextromethorphan

25 mg/15 mg/325

mg Capsule

DECOLSIN Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-6325

TUSERAN

FORTE

Medichem Pharm’ls, Inc.

[United Labs., Inc.]

DR-XY16850

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101

hydrobromide +

Paracetamol

(For Export

Only)

12.5 mg/10

mg/250 mg per 5

mL Oral

Suspension

DECOLSIN Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-6475

Phenoxymethylpenici

llin (as potassium)

250mg Tablet PENICILLIN V

POTASSIUM

Sandoz, Inc.3 Not available

locally

500mg Tablet PENICILLIN V

POTASSIUM

Sandoz, Inc.3 Not available

locally

250 mg Capsule SUMAPEN United American Pharm’ls

[Asian Antibiotics, Inc.]

22-Feb-17

DR-932

500 mg Capsule SUMAPEN United American Pharm’ls

[Asian Antibiotics, Inc.]

22-Feb-17

DR-X513

Phenytoin sodium Prompt-Release

Capsule

The comparator product for Phenytoin Sodium in prompt-release

capsule is not available locally. This should be purchased from a

well regulated market with stringent regulatory authority (SRA).

30 mg Extended-

Release Capsule

DILANTIN Pfizer, Inc. [Interphil

Labs., Inc.]

DR-4639

100 mg Extended-

Release Capsule

DILANTIN Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-2038

30 mg/5 mL Oral

Suspension

DILANTIN Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2042

125 mg/5 mL Oral

Suspension

DILANTIN Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2037

50 mg Chewable

Tablet

EPANUTIN

INFATABS

Pfizer Limited2 Not available

locally

DILANTIN Parke-Davis/Pfizer

Pharmaceuticals Inc.3

Pioglitazone (as

hydrochloride)

15 mg Tablet ACTOS Takeda Pharm’l Phils., Inc.

[Takeda Pharm’l Co., Ltd.

– Japan]

DR-XY26848

30 mg Tablet ACTOS Takeda Pharm’l Phils., Inc.

[Takeda Pharm’l Co., Ltd.

– Japan]

DR-XY26847

45mg Tablet ACTOS Takeda UK Ltd.2 Not available

locally Takeda Pharmaceuticals

USA Inc.3

Pioglitazone (as

hydrochloride) +

Metformin

Hydrochloride

15mg/500mg

Tablet

ACTOPLUS

MET

Takeda Pharmaceuticals

USA Inc.3

Not available

locally

15mg/850mg

Tablet

COMPETACT Takeda UK Ltd.2 Not available

locally ACTOPLUS

MET

Takeda Pharmaceuticals

USA Inc.3

Page 102:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

102

15mg/1g

Extended-Release

Tablet

ACTOPLUS

MET XR

Takeda Pharmaceuticals

USA Inc.3

Not available

locally

30mg/1g

Extended-Release

Tablet

ACTOPLUS

MET XR

Takeda Pharmaceuticals

USA Inc.3

Not available

locally

Piracetam 800 mg Tablet NOOTROPIL GlaxoSmithKline

Philippines, Inc. [UCB

Pharma S.A. – Belgium]

DR-X5323

1.2g Tablet NOOTROPIL GlaxoSmithKline

Philippines, Inc. [UCB

Pharma S.A. – Belgium]

DR-XY19323

Capsule Either one of the abovementioned products should be used as

comparator drug in the conduct of in vivo bioequivalence

studies.

Piribedil 50 mg Sustained-

Release Tablet

TRIVASTAL

RETARD 50

Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-X7970

Piroxicam 10mg Capsule FELDENE Pfizer Limited2 Not available

locally Pfizer Laboratories Div.

Pfizer Inc.3

20 mg Capsule FELDENE Pfizer, Inc. [Pfizer

Pharm’ls Ltd. – China]

DRP-1991

20 mg Tablet FELDENE

FLASH

Pfizer, Inc. [Catalent UK

Swindon Zydis Ltd. –

United Kingdom]

DRP-1990

Pitavastatin (as

calcium)

1 mg Tablet LIVALO Kowa Co. Ltd.[Kowa Co.

Ltd. – Japan or Patheon,

Inc. – USA]3,4

Not available

locally

2 mg Tablet LIVALO Kowa Co. Ltd.[Kowa Co.

Ltd. – Japan or Patheon,

Inc. – USA]3,4

Not available

locally

4 mg Tablet LIVALO Kowa Co. Ltd.[Kowa Co.

Ltd. – Japan or Patheon,

Inc. – USA]3,4

Not available

locally

Posaconazole 40mg/mL Oral

Suspension

NOXAFIL Merck Sharp & Dohme

(I.A.) Corporation

[Patheon, Inc. – Canada]

DR-XY34394

100mg Delayed-

Release Tablet

NOXAFIL Merck Sharp & Dohme

Limited2

Not available

locally

Merck Sharp & Dohme

Corporation3

Potassium citrate 1.080 g (10 mEq)

Tablet

ACALKA Patriot Pharm’ls Corp.

[Ferrer Internacional S.A. –

Spain]

DR-XY20542

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103

1.080 g (10 mEq)

Extended-Release

Tablet

TASCIT Biomedis, Inc. [Amherst

Labs., Inc.]

DR-XY37174

Pramipexole

hydrochloride

125mcg Tablet MIRAPEXIN Boehringer Ingelheim

Limited2

Not available

locally

MIRAPEX Boehringer Ingelheim3

250 mcg Tablet SIFROL Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY27922

500mcg Tablet MIRAPEXIN Boehringer Ingelheim

Limited2

Not available

locally

MIRAPEX Boehringer Ingelheim3

750mcg Tablet MIRAPEX Boehringer Ingelheim3 Not available

locally

1 mg Tablet SIFROL Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY27920

1.5mg Tablet MIRAPEXIN Boehringer Ingelheim

Limited2

Not available

locally

MIRAPEX Boehringer Ingelheim3

375mcg Extended-

Release Tablet

SIFROL ER Boehringer Ingelheim

(Phils.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY39700

750mcg

Prolonged-

/Extended-Release

Tablet

MIRAPEXIN Boehringer Ingelheim

Limited2

Not available

locally

MIRAPEX ER Boehringer Ingelheim3

1.5mg Prolonged-

/Extended-Release

Tablet

MIRAPEXIN Boehringer Ingelheim

Limited2

Not available

locally

MIRAPEX ER Boehringer Ingelheim3

2.25mg Prolonged-

/Extended-Release

Tablet

MIRAPEXIN Boehringer Ingelheim

Limited2

Not available

locally

MIRAPEX ER Boehringer Ingelheim3

3mg Extended-

Release Tablet

SIFROL ER Boehringer Ingelheim

(Phils.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY39702

3.75mg Prolonged-

/Extended-Release

Tablet

MIRAPEXIN Boehringer Ingelheim

Limited2

Not available

locally

MIRAPEX ER Boehringer Ingelheim3

4.5mg Extended-

Release Tablet

SIFROL ER Boehringer Ingelheim

(Phils.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY39701

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104

Prasugrel (as

Hydrochloride)

5mg Tablet EFFIENT Eli Lilly Phils. Inc. [Eli

Lilly and Co. – USA]

DR-XY37670

10mg Tablet EFFIENT Eli Lilly Phils. Inc. [Eli

Lilly and Co. – USA]

DR-XY37671

Pravastatin sodium 20 mg Tablet PRAVAZ Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY33868

PRAVACHOL Bristol Myers Squibb3 Not available

locally

40 mg Tablet PRAVAZ Westmont Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY33869

PRAVACHOL Bristol Myers Squibb3 Not available

locally

80mg Tablet PRAVACHOL Bristol Myers Squibb3 Not available

locally

Praziquantel 600 mg Tablet BILTRICIDE Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-X6396

BILTRICIDE Bayer Healthcare

Pharmaceuticals Inc.2, 3

Not available

locally

Prednisolone 2.5mg Tablet PREDNISOLON

PFIZER

Pfizer AB – Sweden2 Not available

locally

5 mg Tablet Unbranded Ritemed Phils., Inc. [Asian

Antibiotics, Inc.]

DR-8078

PREDNECORT Yung Shin (Phils.), Inc.

[Y.S.P. Industries (M) Sdn.

Bhd. – Malaysia]

DR-XY25965

PREDNISOLON

PFIZER

Pfizer AB – Sweden2 Not available

locally

PREDNISOLON

E

Watson Laboratories Inc.3

10mg Tablet PREDNISOLON

PFIZER

Pfizer AB – Sweden2 Not available

locally

1mg Delayed-

Release Tablet

DELTACORTRI

L

Alliance Pharmaceuticals2 Not available

locally

2.5mg Delayed-

Release Tablet

DELTACORTRI

L

Alliance Pharmaceuticals2 Not available

locally

5mg Delayed-

Release Tablet

DELTACORTRI

L

Alliance Pharmaceuticals2 Not available

locally

15 mg/5 mL Oral

Suspension

PREDISYR Phoenix Pharm’l, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY30309

Prednisolone +

Chlorphenamine

maleate

2 mg/2 mg Tablet HISTACORT Biofemme, Inc. [Asian

Antibiotics, Inc.]

DR-2328

Prednisolone (as

Sodium Phosphate)

10mg Orally

Disintegrating

Tablet

ORAPRED ODT Concordia Pharmaceuticals

Inc.3

Not available

locally

Page 105:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

105

15mg Orally

Disintegrating

Tablet

ORAPRED ODT Concordia Pharmaceuticals

Inc.3

Not available

locally

30mg Orally

Disintegrating

Tablet

ORAPRED ODT Concordia Pharmaceuticals

Inc.3

Not available

locally

Prednisone 1mg Tablet PREDNISONE West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

2.5mg Tablet PREDNISONE West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

5 mg Tablet ORASONE 5 Phoenix Pharm’l, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY1584

PREDNISONE West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

10 mg Tablet ORASONE 10 Phoenix Pharm’l, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY33699

PREDNISONE West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

20 mg Tablet ORASONE 20 Phoenix Pharm’l, Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY22998

PREDNISONE West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

50mg Tablet PREDNISONE West-Ward

Pharmaceuticals

International Ltd.3

Not available

locally

1mg Delayed-

Release Tablet

RAYOS Horizon Pharma Inc.3 Not available

locally

2mg Delayed-

Release Tablet

RAYOS Horizon Pharma Inc.3 Not available

locally

5mg Delayed-

Release Tablet

RAYOS Horizon Pharma Inc.3 Not available

locally

Pregabalin 25 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY32505

50 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY32506

Page 106:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

106

75 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY30678

100 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY32507

150 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY30679

200 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY32504

225mg Capsule LYRICA Pfizer Limited2 Not available

locally PF Prism CV3

300 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY31133

82.5mg Extended-

Release Tablet

LYRICA CR Pfizer Inc.3 Not available

locally

165mg Extended-

Release Tablet

LYRICA CR Pfizer Inc.3 Not available

locally

330mg Extended-

Release Tablet

LYRICA CR Pfizer Inc.3 Not available

locally

Primaquine (as

Phosphate)

15mg Tablet PRIMAQUINE Sanofi Aventis US LLC3 Not available

locally

Procaterol

Hydrochloride

25mcg Tablet MEPTIN Otsuka (Phils.)

Pharmaceutical, Inc.

[Taiwan Otsuka

Pharmaceutical Co., Ltd. –

Taiwan]

DR-XY26745

50mcg Tablet MEPTIN Otsuka (Phils.)

Pharmaceutical, Inc.

[Taiwan Otsuka

Pharmaceutical Co., Ltd. –

Taiwan]

DR-XY26744

Progesterone 100 mg Softgel

Capsule

UTROGESTAN A. Menarini Phils., Inc.

[Besins Manufacturing

Belgium S.A. – Belgium]

DR-XY37229

200 mg Softgel

Capsule

UTROGESTAN A. Menarini Phils., Inc.

[Besins Manufacturing

Belgium S.A. – Belgium]

DR-XY37230

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107

Propranolol

hydrochloride

10 mg Tablet INDERAL AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

UK Ltd. – United

Kingdom]

DR-XY14078

40 mg Tablet INDERAL AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

UK Ltd. – United

Kingdom]

DR-XY14079

60mg Extended-

Release Capsule

INDERAL LA Ani Pharmaceuticals Inc.3 Not available

locally

80mg Extended-

Release Capsule

INDERAL LA Ani Pharmaceuticals Inc.3 Not available

locally

120mg Extended-

Release Capsule

INDERAL LA Ani Pharmaceuticals Inc.3 Not available

locally

160mg Extended-

Release Capsule

INDERAL LA Ani Pharmaceuticals Inc.3 Not available

locally

Propylthiouracil 50 mg Tablet Unbranded Philusa Corp. [Surepharm

Services Ltd. – United

Kingdom]

DR-XY2509

PROPYLTHIOU

RACIL

Dava Pharmaceuticals Inc.3 Not available

locally

Prucalopride (as

Succinate)

1mg Tablet RESOLOR Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

S.p.A. – Italy]

DR-XY40717

2mg Tablet RESOLOR Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

S.p.A. – Italy]

DR-XY40715

Pyrantel embonate 125 mg Tablet COMBANTRIN Johnson & Johnson

(Phils.), Inc. [PT. Pfizer

Indonesia – Indonesia]

DR-769

250 mg Tablet COMBANTRIN Johnson & Johnson

(Phils.), Inc. [PT. Pfizer

Indonesia – Indonesia]

DR-X1110

125 mg/5 mL Oral

Suspension

COMBANTRIN Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-X2920

Pyrantel embonate +

Oxantel embonate

100 mg/100 mg

Tablet

QUANTREL Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-X7039

20 mg/20 mg per

mL (100 mg/100

mg per 5 mL) Oral

Suspension

QUANTREL Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-X7040

Pyrazinamide 500 mg Tablet PZA-CIBA Sandoz Phils. Corp.

[Interphil Labs., Inc.]

DR-XY25118

Unbranded Pharex Health Corp.

[Pascual Labs., Inc.]

DR-XY9200

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108

250 mg/5 mL Oral

Suspension

PZA-CIBA Sandoz Phils. Corp.

[Interphil Labs., Inc.]

DR-XY25264

ZCURE Natrapharm, Inc. [Lloyd

Labs., Inc.]

DR-XY27677

500 mg/5 mL Oral

Suspension

ZCURE FORTE Natrapharm, Inc. [Lloyd

Labs., Inc.]

DR-XY35466

Pyridostigmine

Bromide

60mg Tablet MESTINON A. Menarini Philippines,

Inc. [Labiana

Pharmaceutical – Spain]

DR-6724

180mg Extended-

Release Tablet

MESTINON Valeant Pharmaceuticals

North America LLC3

Not available

locally

Quetiapine (as

fumarate)

25 mg Tablet SEROQUEL AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co., Ltd. – China]

DR-XY25575

50mg Tablet SEROQUEL AstraZeneca

Pharmaceuticals LP3

Not available

locally

100 mg Tablet SEROQUEL AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co., Ltd. – China]

DR-XY25574

200 mg Tablet SEROQUEL AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’l Co., Ltd. – China]

DR-XY25573

300 mg Tablet SEROQUEL AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

UK Ltd. – United

Kingdom/AstraZeneca

Pharm’l Co., Ltd. – China]

DR-XY30815

400mg Tablet SEROQUEL AstraZeneca

Pharmaceuticals LP3

Not available

locally

50 mg Extended-

Relase Tablet

SEROQUEL XR AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’ls LP – USA]

DR-XY34644

150 mg Extended-

Relase Tablet

SEROQUEL XR AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’ls LP – USA]

DR-XY37721

200 mg Extended-

Relase Tablet

SEROQUEL XR AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’ls LP – USA]

DR-XY34617

300 mg Extended-

Relase Tablet

SEROQUEL XR AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’ls LP – USA]

DR-XY34318

400 mg Extended-

Relase Tablet

SEROQUEL XR AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’ls LP – USA]

DR-XY34317

Quinapril (as

Hydrochloride)

5mg Tablet ACCUPRIL Pfizer, Inc. [Pfizer

Manufacturing

DRP-2002

Page 109:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

109

Deutschland GmbH –

Germany]

10mg Tablet ACCUPRIL Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-3124

20mg Tablet ACCUPRIL Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-3104

40mg Tablet ACCUPRO Pfizer Limited2 Not available

locally ACCUPRIL Pfizer Pharmaceuticals

Limited3

Quinapril (as

Hydrochloride) +

Hydrochlorothiazide

10mg/12.5mg

Tablet

ACCURETIC Pfizer Limited2 Not available

locally Pfizer Pharmaceuticals

Limited3

20mg/12.5mg

Tablet

ACCUZIDE Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-2001

20mg/25mg Tablet ACCURETIC Pfizer Pharmaceuticals

Limited3

Not available

locally

Quinine sulfate 325 mg Tablet Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-X1607

324mg Capsule QUININE

SULFATE

Sun Pharmaceutical

Industries Inc.3

Not available

locally

Rabeprazole Sodium 10mg (Delayed-

Release) Tablet

PARIET Hi-Eisai Pharmaceutical,

Inc. [Bushu Pharmaceutical

Ltd. – Japan]

DR-XY25304

20mg (Delayed-

Release) Tablet

PARIET Hi-Eisai Pharmaceutical,

Inc. [Bushu Pharmaceutical

Ltd. – Japan]

DR-XY25303

5mg Delayed-

Release Capsule

ACIPHEX

SPRINKLE

FSC Therapeutics LLC3 Not available

locally

10mg Delayed-

Release Capsule

ACIPHEX

SPRINKLE

FSC Therapeutics LLC3 Not available

locally

Racecadotril 10mg Powder for

Oral Suspension

HIDRASEC Abbott Laboratories

[Sophartex – France]

DR-XY31236

30mg Powder for

Oral Suspension

HIDRASEC Abbott Laboratories

[Sophartex – France]

DR-XY31237

100mg Capsule HIDRASEC Abbott Laboratories

[Sophartex – France]

DR-XY31139

Raloxifene

hydrochloride

60 mg Tablet EVISTA Takeda Pharm’ls (Phils.),

Inc. [Lilly S.A. – Spain]

DR-XY24477

Raltegravir (as

Potassium)

400mg Tablet ISENTRESS Merck Sharp & Dohme

(I.A.) Corporation [MSD

DR-XY38812

Page 110:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

110

International GmbH –

Singapore]

600mg Tablet ISENTRESS HD Merck Sharp and Dohme

Corp.3

Not available

locally

25mg Chewable

Tablet

ISENTRESS Merck Sharp and Dohme

Limited2

Not available

locally

Merck Sharp and Dohme

Corp.3

100mg Chewable

Tablet

ISENTRESS Merck Sharp and Dohme

Limited2

Not available

locally

Merck Sharp and Dohme

Corp.3

100mg Oral

Powder

ISENTRESS Merck Sharp and Dohme

Corp.3

Not available

locally

100mg Granules

for Oral

Suspension

ISENTRESS Merck Sharp and Dohme

Limited2

Not available

locally

Ramelteon 8mg Tablet ROZEREM Takeda Pharmaceutical

Phils. Inc. [Takeda

Pharmaceutical Co. Ltd. –

Ireland]

DR-XY34667

Ramipril

1.25mg Tablet TRITACE Sanofi2 Not available

locally ALTACE King Pharmaceuticals Inc.3

2.5 mg Tablet TRITACE Sanofi-Aventis [PT.

Aventis Pharma –

Indonesia]

DRP-089

5 mg Tablet TRITACE Sanofi-Aventis [PT.

Aventis Pharma –

Indonesia]

DRP-170

10 mg Tablet TRITACE Sanofi-Aventis [PT.

Aventis Pharma –

Indonesia]

DRP-121

Ramosetron

Hydrochloride

100mcg Orally-

Disintegrating

Tablet

NASEA OD Astellas Pharma Phils. Inc.

[Seiko Eiyo Yakuhin Co.,

Ltd. – Japan]

DR-XY40865

Ranitidine (as

hydrochloride)

75 mg Tablet ZANTAC GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

(Tianjin) Co. Ltd. – China]

DR-XY22461

150 mg Tablet ZANTAC GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

(Tianjin) Co. Ltd. – China]

DR-XY1971

300 mg Tablet ZANTAC GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

(Tianjin) Co. Ltd. – China]

DR-XY3594

Ranolazine 375 mg Prolonged-

/Extended-Release

Tablet

RANEXA A. Menarini Philippines,

Inc. [Menarini-Von

DR-XY43915

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111

Heyden GmbH –

Germany]

500 mg Prolonged-

/Extended-Release

Tablet

RANEXA

A. Menarini Philippines,

Inc. [Menarini-Von

Heyden GmbH –

Germany]

DR-XY43914

750 mg Prolonged-

/Extended-Release

Tablet

RANEXA A. Menarini Philippines,

Inc. [Menarini-Von

Heyden GmbH –

Germany]

DR-XY43913

1 g Extended-

Release Tablet

RANEXA Gilead Sciences, Inc.3 Not available

locally

Rasagiline (as

Mesilate)

500mcg Tablet AZILECT Teva Neuroscience Inc.3 Not available

locally

1mg Tablet AZILECT Metro Drug Inc. [Teva

Pharmaceutical Industries

Ltd. – Israel]

DR-XY43609

Rebamipide 100 mg Tablet MUCOSTA Otsuka (Phils.)

Pharmaceutical, Inc.

[Korea Otsuka

Pharmaceutical Co. Ltd. –

Korea]

DRP-6921

(DR-XY20097)

Regorafenib 40mg Tablet STIVARGA Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DR-XY43344

Repaglinide 500mcg Tablet NOVONORM Novo Nordisk

Pharmaceuticals (Phils.)

Inc. [Boehringer Ingelheim

Pharma KG – Germany]

DR-XY25437

1mg Tablet NOVONORM Novo Nordisk

Pharmaceuticals (Phils.)

Inc. [Boehringer Ingelheim

Pharma KG – Germany]

DR-XY25438

2mg Tablet NOVONORM Novo Nordisk

Pharmaceuticals (Phils.)

Inc. [Boehringer Ingelheim

Pharma KG – Germany]

DR-XY25439

Repaglinide +

Metformin

Hydrochloride

1mg/500mg Tablet PRANDIMET Novo Nordisk Inc.3 Not available

locally

2mg/500mg Tablet PRANDIMET Novo Nordisk Inc.3 Not available

locally

Retigabine 50mg Tablet TROBALT GlaxoSmithKline Phils.

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY42838

100mg Tablet TROBALT GlaxoSmithKline Phils.

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY42839

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112

200mg Tablet TROBALT GlaxoSmithKline Phils.

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY42480

300mg Tablet TROBALT GlaxoSmithKline Phils.

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY42841

400mg Tablet TROBALT GlaxoSmithKline Phils.

Inc. [GlaxoSmithKline

LLC – USA]

DR-XY42842

Ribavirin 200mg Capsule REBETOL Merck Sharp & Dohme

(I.A.) Corp. [MSD

International GmbH –

USA]

DR-XY25844

200mg Tablet COPEGUS Roche (Phils.), Inc.

[Patheon Inc. – Canada]

DR-XY42923

400mg Tablet COPEGUS Roche Products Limited2 Not available

locally

Rifampicin 300 mg Capsule RIMACTANE Sandoz Phils. Corp.

[Interphil Labs., Inc.]

DR-XY25116

600 mg Tablet RIMACTANE Sandoz Phils. Corp.

[Interphil Labs., Inc.]

DR-XY25117

100mg/5mL Oral

Suspension

RIFADIN Sanofi2 Not available

locally

200 mg/5 mL Oral

Suspension

NATRICIN

FORTE

Natrapharm, Inc. [Lloyd

Labs., Inc.]

DR-XY23213

Rifampicin +

Isoniazid

150 mg/75 mg

Tablet

BIFIX United American Pharm’ls,

Inc. [Amherst Labs, Inc.]

DR-XY28918

MYRIN I Pfizer, Inc. [Wyeth

Pakistan Ltd. – Pakistan]

DRP-6598

(DR-XY40593)

150mg/100mg

Tablet

RIFINAH Sanofi2 Not available

locally

300 mg/150 mg

Tablet

RIMACTAZID Sandoz Phils. Corp.

[Interphil Labs., Inc.]

DR-XY25265

RIFINAH Sanofi2 Not available

locally RIFAMATE Sanofi-Aventis US LLC3

450 mg/400 mg

Tablet

RIMACTAZID Sandoz Phils. Corp.

[Interphil Labs., Inc.]

DRP-5099

(DR-XY25238)

Rifampicin +

Ethambutol +

Isoniazid

150 mg/300 mg/75

mg Tablet

MYRIN Pfizer, Inc. [Wyeth

Pakistan Ltd. – Pakistan]

DRP-3365

(DR-XY23595)

Rifampicin +

Isoniazid +

Pyrazinamide

120mg/50mg/300

mg Tablet

RIFATER Sanofi-Aventis US LLC3 Not available

locally

Rifampicin +

Ethambutol +

Isoniazid +

Pyrazinamide

150 mg/275 mg/75

mg/400 mg Tablet

MYRIN P

FORTE

Pfizer, Inc. [Wyeth

Pakistan Ltd. – Pakistan]

DRP-3810

(DR-XY23682)

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113

Risedronate Sodium 5mg Tablet ACTONEL Warner Chilcott UK

Limited (a subsidiary of

Activis PLC)2

Not available

locally

Allergan Pharmaceuticals

International Ltd.3

30mg Tablet ACTONEL Warner Chilcott UK

Limited (a subsidiary of

Activis PLC)2

Not available

locally

Allergan Pharmaceuticals

International Ltd.3

35mg Tablet ACTONEL Sanofi-Aventis Philippines

Inc. [Norwich

Pharmaceutical Inc. –

USA]

DRP-5169

150mg Tablet ACTONEL Allergan Pharmaceuticals

International Ltd.3

Not available

locally

35mg Delayed-

Release Tablet

ATELVIA Allergan Pharmaceuticals

International Ltd.3

Not available

locally

Risperidone 250mcg Tablet RISPERDAL Janssen Pharmaceuticals

Inc.3

Not available

locally

500mcg Tablet RISPERDAL Janssen-Cilag Ltd.2 Not available

locally Janssen Pharmaceuticals

Inc.3

1 mg Tablet RISPERDAL Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

S.p.A. – Italy]

DR-XY40691

2 mg Tablet RISPERDAL Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

S.p.A. – Italy]

DR-XY40690

3mg Tablet RISPERDAL Janssen-Cilag Ltd.2 Not available

locally Janssen Pharmaceuticals

Inc.3

4 mg Tablet RISPERDAL Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

S.p.A. – Italy]

DR-XY26976

6mg Tablet RISPERDAL Janssen-Cilag Ltd.2 Not available

locally

500mcg

Orodispersible

Tablet

RISPERDAL

QUICKLET

Janssen-Cilag Ltd.2 Not available

locally

RISPERDAL Janssen Pharmaceuticals

Inc.3

1 mg

Orodispersible

Tablet

RISPERDAL

QUICKLET

Johnson & Johnson

(Phils.), Inc. [Janssen-

Ortho LLC – Puerto Rico]

DR-XY30041

2 mg

Orodispersible

Tablet

RISPERDAL

QUICKLET

Johnson & Johnson

(Phils.), Inc. [Janssen-

Ortho LLC – Puerto Rico]

DR-XY30048

Page 114:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

114

3mg

Orodispersible

Tablet

RISPERDAL

QUICKLET

Janssen-Cilag Ltd.2 Not available

locally

RISPERDAL Janssen Pharmaceuticals

Inc.3

4mg

Orodispersible

Tablet

RISPERDAL

QUICKLET

Janssen-Cilag Ltd.2 Not available

locally

RISPERDAL Janssen Pharmaceuticals

Inc.3

Rivaroxaban 2.5mg Tablet XARELTO Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY44605

10 mg Tablet XARELTO Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY35756

15 mg Tablet XARELTO Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY40850

20 mg Tablet XARELTO Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY40851

Rivastigmine (as

hydrogen tartrate)

1.5 mg Capsule EXELON Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY24675

3 mg Capsule EXELON Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY24670

4.5 mg Capsule EXELON Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY24672

6 mg Capsule EXELON Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY24671

Roflumilast 500 mcg Tablet DAXAS Nycomed Philippines

[Takeda GmbH –

Germany]

DR-XY40659

Ropinirole (as

Hydrochloride)

250mcg Tablet ADARTREL GlaxoSmithKline UK2 Not available

locally REQUIP

GlaxoSmithkline LLC3

500mcg Tablet ADARTREL GlaxoSmithKline UK2 Not available

locally REQUIP GlaxoSmithkline LLC3

1mg Tablet REQUIP GlaxoSmithKline UK2 Not available

locally GlaxoSmithkline LLC3

2mg Tablet ADARTREL GlaxoSmithKline UK2 Not available

locally REQUIP

GlaxoSmithkline LLC3

3mg Tablet REQUIP GlaxoSmithkline LLC3 Not available

locally

4mg Tablet REQUIP GlaxoSmithkline LLC3 Not available

locally

5mg Tablet REQUIP GlaxoSmithKline UK2 Not available

locally GlaxoSmithkline LLC3

Page 115:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

115

2mg Prolonged-

/Extended-Release

Tablet

REQUIP PD GlaxoSmithKline

Philippines Inc. [Glaxo

Wellcome S.A. – Spain]

DR-XY38191

4mg Prolonged-

/Extended-Release

Tablet

REQUIP PD GlaxoSmithKline

Philippines Inc. [Glaxo

Wellcome S.A. – Spain]

DR-XY38190

6mg Prolonged-

/Extended-Release

Tablet

REQUIP GlaxoSmithkline LLC3 Not available

locally

8mg Prolonged-

/Extended-Release

Tablet

REQUIP PD GlaxoSmithKline

Philippines Inc. [Glaxo

Wellcome S.A. – Spain]

DR-XY38193

12mg Prolonged-

/Extended-Release

Tablet

REQUIP GlaxoSmithkline LLC3 Not available

locally

Rosiglitazone (as

Maleate)

2mg Tablet AVANDIA SB Pharmco Puerto Rico

Inc.3

Not available

locally

4mg Tablet AVANDIA SB Pharmco Puerto Rico

Inc.3

Not available

locally

8mg Tablet AVANDIA SB Pharmco Puerto Rico

Inc.3

Not available

locally

Rosuvastatin calcium 5 mg Tablet CRESTOR AstraZeneca Pharm’ls

(Phils.), Inc. [IPR Pharm’l

Inc. – Puerto Rico]

DR-XY31354

10 mg Tablet CRESTOR AstraZeneca Pharm’ls

(Phils.), Inc. [IPR Pharm’l

Inc. – Puerto Rico]

DR-XY28499

20 mg Tablet CRESTOR AstraZeneca Pharm’ls

(Phils.), Inc. [IPR Pharm’l

Inc. – Puerto Rico]

DR-XY28498

40 mg Tablet CRESTOR AstraZeneca Pharm’ls

(Phils.), Inc. [IPR Pharm’l

Inc. – Puerto Rico]

DR-XY28497

Roxithromycin 150mg Tablet RULID Sanofi-Aventis Philippines,

Inc. [PT Aventis Pharma –

Indonesia]

DRP-1914

300mg Tablet RULID Sanofi-Aventis Philippines,

Inc. [PT Aventis Pharma –

Indonesia]

DRP-2130

Rufinamide 100mg Tablet INOVELON Eisai Ltd.2 Not available

locally

200mg Tablet INOVELON Hi-Eisai Pharmaceutical

Inc. [Bushu

Pharmaceuticals Ltd.

(Misato Factory) – Japan]

DR-XY45877

400mg Tablet INOVELON Eisai Ltd.2 Not available

locally BANZEL Eisai Inc.3

Page 116:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

116

40mg/mL Oral

Suspension

INOVELON Eisai Ltd.2 Not available

locally BANZEL Eisai Inc.3

Rupatadine (as

Fumarate)

10mg Tablet RUPAFIN Hyphens Pharma

Philippines, Inc. [J. Uriach

& Cia S.A. – Spain]

DR-XY41982

Ruxolitinib (as

Phosphate)

5mg Tablet JAKAVI Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY43376

10mg Tablet JAKAVI Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY45844

15mg Tablet JAKAVI Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY43377

20mg Tablet JAKAVI Novartis Healthcare

Philippines, Inc. [Novartis

Pharma Stein AG –

Switzerland]

DR-XY43378

25mg Tablet JAKAVI Incyte Corp.3 Not available

locally

Salbutamol (as

sulfate)

2 mg Tablet VENTOLIN GlaxoSmithKline Phils.,

Inc. [Aspen Bad Oldesloe

GmbH – Germany]

DRP-6319

(DR-6009)

Salbutamol sulfate +

Guaifenesin

2 mg/100 mg

Capsule

VENTOLIN EXPECTORANT

GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

(Phils.)]

DRP-4347

(DR-XY10751)

Saxagliptin (as

Hydrochloride)

2.5mg Tablet ONGLYZA AstraZeneca

Pharmaceuticals (Phils.),

Inc. [Bristol-Myers Squibb

Company – USA]

DR-XY38014

5mg Tablet ONGLYZA AstraZeneca

Pharmaceuticals (Phils.),

Inc. [Bristol-Myers Squibb

Company – USA]

DR-XY38015

Saxagliptin (as

Hydrochloride) +

Metformin

Hydrochloride

2.5mg/850mg

Tablet

KOMBOGLYZ

E

AstraZeneca UK Limited2 Not available

locally

2.5mg/1g Tablet KOMBIGLYZE

XR

AstraZeneca

Pharmaceuticals (Phils.),

Inc. [Bristol-Myers Squibb

Company – USA]

DR-XY40720

5mg/500mg Tablet KOMBIGLYZE

XR

AstraZeneca

Pharmaceuticals (Phils.),

Inc. [Bristol-Myers Squibb

Company – USA]

DR-XY40719

Page 117:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

117

5mg/1g Tablet KOMBIGLYZE

XR

AstraZeneca

Pharmaceuticals (Phils.),

Inc. [Bristol-Myers Squibb

Company – USA]

DR-XY40718

Selegiline

Hydrochloride

5mg Tablet JUMEX Sanofi-Aventis Phils., Inc.

[Chinoin Pharmaceutical

and Chemical Works Pvt.

Co. Ltd. – Hungary]

DR-XY22717

10mg Tablet ELDEPRYL Orion Pharma (UK)

Limited2

Not available

locally

1.25mg Orally

Disintegrating

Tablet

ZELAPAR Cephalon (UK) Limited2 Not available

locally Valeant Pharmaceuticals

International3

Sertraline (as

hydrochloride)

25mg Tablet ZOLOFT Pfizer Pharmaceuticals

Inc.3

Not available

locally

50 mg Tablet ZOLOFT Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-1931

100mg Tablet LUSTRAL Pfizer Limited2 Not available

locally ZOLOFT Pfizer Pharmaceuticals

Inc.3

Sevelamer carbonate 800mg Tablet RENVELA Sanofi-Aventis Philippines,

Inc. [Genzyme Ireland Ltd.

– Ireland]

DRP-5212

(DR-XY36510)

800mg Powder for

Oral Suspension

RENVELA Genzyme Corp.3 Not available

locally

2.4g Powder for

Oral Suspension

RENVELA Sanofi2 Not available

locally Genzyme Corp.3

Sevelamer

Hydrochloride

400mg Tablet RENAGEL Genzyme Corp.3 Not available

locally

800mg Tablet RENAGEL Genzyme Corp.3 Not available

locally

Sildenafil (as citrate) 20mg Tablet REVATIO Pfizer Inc.3 Not available

locally

25 mg Tablet VIAGRA Pfizer, Inc. [Pfizer PGM –

France]

DRP-3434

50 mg Tablet VIAGRA Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-2072

100 mg Tablet VIAGRA Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-2073

10mg/mL Powder

for Oral

Suspension

REVATIO Pfizer Inc.3 Not available

locally

Page 118:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

118

Simethicone 40mg Chewable

Tablet

DISFLATYL A. Menarini Philippines,

Inc. [Olic (Thailand)

Limited – Thailand]

DR-XY40471

Simethicone +

Alverine Citrate

300mg/60mg

Softgel Capsule

AVARIN Metro Drug, Inc. [Mega

Lifesciences Public

Company Limited –

Thailand]

DR-XY37780

Silodosin 4mg Tablet URIEF Hi-Eisai Pharmaceutical

Inc. [Kissei Pharmaceutical

Co. Ltd. – Japan]

DR-XY44043

4mg Capsule RAPAFLO Allergan Sales LLC3 Not available

locally

8mg Capsule RAPAFLO Allergan Sales LLC3 Not available

locally

Simvastatin 5mg Tablet ZOCOR Merch Research

Laboratories Div. Merck

Co. Inc.3

Not available

locally

10 mg Tablet ZOCOR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DR-XY14848

20 mg Tablet ZOCOR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-6241

(DR-XY14849)

40 mg Tablet

ZOCOR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DR-XY23881

ZOCOR HP Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-6243

80 mg Tablet ZOCOR Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-6242

(DR-XY27257)

20mg/5mL Oral

Suspension

SIMVASTATIN TCG Fluent Pharma

Investors LP3

Not available

locally

40mg/5mL Oral

Suspension

SIMVASTATIN TCG Fluent Pharma

Investors LP3

Not available

locally

Sirolimus 500mcg Tablet RAPAMUNE Pfizer, Inc. [Pfizer Ireland

Pharmaceutical – Ireland]

DR-XY40263

1mg Tablet RAPAMUNE Pfizer, Inc. [Pfizer Ireland

Pharmaceutical – Ireland]

DR-XY27395

2mg Tablet RAPAMUNE Pfizer Limited2 Not available

locally PF Prism CV3

Page 119:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

119

Sitagliptin (as

phosphate)

25 mg Tablet

JANUVIA Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme S.p.A. – Italy]

DRP-2544

Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-5943

50 mg Tablet

JANUVIA Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme S.p.A. – Italy]

DRP-2545

Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-5945

100 mg Tablet

JANUVIA Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme S.p.A. – Italy]

DRP-2529

Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme Ltd. – United

Kingdom]

DRP-5944

Sitagliptin (as

phosphate) +

Metformin

hydrochloride

50 mg/500 mg

Tablet

JANUMET Merck Sharp & Dohme

(I.A.) Corp. [Patheon

Puerto Rico, Inc. – Puerto

Rico]

DRP-4010

(DR-XY34333)

50 mg/850 mg

Tablet

JANUMET Merck Sharp & Dohme

(I.A.) Corp. [Patheon

Puerto Rico, Inc. – Puerto

Rico]

DRP-4011

50 mg/1 g Tablet JANUMET Merck Sharp & Dohme

(I.A.) Corp. [Patheon

Puerto Rico, Inc. – Puerto

Rico]

DRP-4012

50mg/500mg

Extended-Release

Tablet

JANUMET XR Merck Sharp & Dohme

Corp.3

Not available

locally

50mg/1g

Extended-Release

Tablet

JANUMET XR Merck Sharp & Dohme

Corp.3

Not available

locally

100 mg/1 g

Extended-Release

Tablet

JANUMET XR Merck Sharp & Dohme

(I.A.) Corp. [MSD Int’l

GmbH – Germany]

DRP-5360

Sitagliptin (as

phosphate) +

Simvastatin

100mg/10mg

Tablet

JUVICOR Merck Sharp & Dohme

(I.A.) Corp. [MSD

International GmbH –

Ireland]

DR-XY42720

Page 120:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

120

100mg/20mg

Tablet

JUVICOR Merck Sharp & Dohme

(I.A.) Corp. [MSD

International GmbH –

Ireland]

DR-XY42721

100mg/40mg

Tablet

JUVICOR Merck Sharp & Dohme

(I.A.) Corp. [MSD

International GmbH –

Ireland]

DR-XY42722

Sofosbuvir 400 mg Tablet SOVALDI LF (Phils.), Inc. [Patheon

Inc. – Canada]

DR-XY44852

Solifenacin succinate 5 mg Tablet VESICARE Astellas Pharma Phils., Inc.

[Astellas Pharma Europe

B.V. – Netherlands]

DR-XY31747

10 mg Tablet VESICARE Astellas Pharma Phils., Inc.

[Astellas Pharma Europe

B.V. – Netherlands]

DR-XY31760

Solifenacin succinate

+ Tamsulosin

hydrochloride

6 mg/400 mcg

Modified-Release

Tablet

VESOMNI Astellas Pharma Ltd.2 Not available

locally

Sorafenib (as tosilate) 200mg Tablet NEXAVAR Bayer Philippines Inc.

[Bayer Pharma AG –

Germany]

DR-XY32442

Sotalol

Hydrochloride

80mg Tablet SOTACOR Bristol-Myers Squibb

Holdings Limited2

Not available

locally

BETAPACE Covis Pharma BV3

BETAPACE AF

120mg Tablet BETAPACE Covis Pharma BV3 Not available

locally BETAPACE AF

160mg Tablet BETAPACE Covis Pharma BV3 Not available

locally BETAPACE AF

240mg Tablet BETAPACE Covis Pharma BV3 Not available

locally

Spironolactone 25 mg Tablet ALDACTONE Pfizer, Inc. [Piramal

Healthcare UK Ltd. –

United Kingdom]

DRP-2016

50 mg Tablet ALDACTONE Pfizer, Inc. [Piramal

Healthcare UK Ltd. –

United Kingdom]

DRP-2013

100 mg Tablet ALDACTONE Pfizer, Inc. [Piramal

Healthcare UK Ltd. –

United Kingdom]

DRP-2014

Spironolactone +

Hydrochlorothiazide

25mg/25mg Tablet ALDACTAZID

E

GD Searle LLC3 Not available

locally

50mg/50mg Tablet ALDACTAZID

E

GD Searle LLC3 Not available

locally

Page 121:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

121

Spironolactone +

Hydroflumethiazide

25 mg/25 mg

Tablet

ALDAZIDE Pfizer, Inc. [Piramal

Healthcare UK Ltd. –

United Kingdom]

DR-7294

50mg/50mg Tablet ALDACTIDE Pfizer Limited2 Not available

locally

Strontium ranelate 2 g

Powder/Granules

for Oral

Suspension

PROTOS Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY31021

Sucralfate 1g Tablet ISELPIN Pfizer Inc. [Interphil Labs.

Inc.]

DR-XY3501

1g/10mL Oral

Suspension

CARAFATE Forest Laboratories Inc.3 Not available

locally

1g/5mL Oral

Suspension

ANTEPSIN Chugai Pharma UK

Limited2

Not available

locally

Sulbutiamine 200 mg Tablet ARCALION Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-X9366

Sulfadoxine +

Pyrimethamine

500 mg/25 mg

Tablet

FANSIDAR Roche (Phils.), Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-9514

Sultamicillin tosilate 375 mg Tablet UNASYN Pfizer, Inc. [Pfizer Japan

Inc. – Japan]

DRP-3451

(DR-XY15597)

750 mg Tablet UNASYN Pfizer, Inc. [Haupt Pharma

Latina S.r.l. – Italy]

DRP-2076

250 mg/5 mL

Powder for Oral

Suspension

UNASYN Pfizer, Inc. [Haupt Pharma

Latina S.r.l. – Italy]

DRP-2015

(DR-XY13059)

Sumatriptan (as

succinate)

25mg Tablet IMITREX GlaxoSmithKline3 Not available

locally

50 mg Tablet IMIGRAN GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Pharm’ls S.A. – Poland]

DR-XY20944

100mg Tablet IMIGRAN GlaxoSmithKline UK2 Not available

locally IMITREX GlaxoSmithKline3

Sunitinib (as

Maleate)

12.5mg Capsule SUTENT Pfizer, Inc. [Pfizer Italia

S.r.l. – Italy]

DRP-2096

DR-XY42990

25mg Capsule SUTENT Pfizer, Inc. [Pfizer Italia

S.r.l. – Italy]

DRP-2095

DR-XY42992

37.5mg Capsule SUTENT Pfizer Limited2 Not available

locally CP Pharmaceuticals

International CV3

50mg Capsule SUTENT Pfizer, Inc. [Pfizer Italia

S.r.l. – Italy]

DRP-2098

DR-XY42991

Tacrolimus (as

monohydrate)

500 mcg Capsule PROGRAF Astellas Pharma Phils., Inc.

[Astellas Ireland Co. Ltd. –

Ireland]

DR-XY34549

Page 122:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

122

1 mg Capsule PROGRAF Astellas Pharma Phils., Inc.

[Astellas Ireland Co. Ltd. –

Ireland]

DR-XY24868

5 mg Capsule PROGRAF Astellas Pharma Phils., Inc.

[Astellas Ireland Co. Ltd. –

Ireland]

DR-XY24870

500 mcg

Prolonged-Release

Capsule

ADVAGRAF Astellas Pharma Phils., Inc.

[Astellas Ireland Co. Ltd. –

Ireland]

DR-XY43434

1 mg Prolonged-

Release Capsule

ADVAGRAF Astellas Pharma Phils., Inc.

[Astellas Ireland Co. Ltd. –

Ireland]

DR-XY43435

3mg Prolonged-

Release Capsule

ADVAGRAF Astellas Pharma Ltd.2 Not available

locally

5 mg Prolonged-

Release Capsule

ADVAGRAF Astellas Pharma Phils., Inc.

[Astellas Ireland Co. Ltd. –

Ireland]

DR-XY43436

200mcg Granules

for Oral

Suspension

MODIGRAF Astellas Pharma Ltd.2 Not available

locally

1mg Granules for

Oral Suspension

MODIGRAF Astellas Pharma Ltd.2 Not available

locally

750mcg Extended-

Release Tablet

ENVARSUS XR Veloxis Pharmaceuticals

Inc.3

Not available

locally

1mg Extended-

Release Tablet

ENVARSUS XR Veloxis Pharmaceuticals

Inc.3

Not available

locally

4mg Extended-

Release Tablet

ENVARSUS XR Veloxis Pharmaceuticals

Inc.3

Not available

locally

Tadalafil 2.5 mg Tablet CIALIS Eli Lilly (Phils.), Inc. [Lilly

del Caribe, Inc. – Puerto

Rico]

DR-XY43862

5 mg Tablet CIALIS Eli Lilly (Phils.), Inc. [Lilly

del Caribe, Inc. – Puerto

Rico]

DR-XY43863

10mg Tablet CIALIS Eli Lilly and Company

Limited2

Not available

locally

Eli Lilly and Co.3

20 mg Tablet CIALIS Eli Lilly (Phils.), Inc. [Lilly

del Caribe, Inc. – Puerto

Rico]

DR-XY44985

Tamoxifen (as

citrate)

20 mg Tablet NOLVADEX-D AstraZeneca

Pharmaceutical Phils., Inc.

[AstraZeneca UK Ltd. –

United Kingdom]

DR-XY14048

40 mg Tablet NOLVADEX AstraZeneca2, 3 Not available

locally

Page 123:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

123

Tamsulosin

hydrochloride

200 mcg Capsule HARNAL Astellas Pharma Phils., Inc.

[Astellas Tokai Co., Ltd. –

Japan]

DR-XY21814

400mcg Capsule FLOMAX Boehringer Ingelheim

Pharmaceuticals Inc.3

Not available

locally

200 mcg Tablet HARNAL D Astellas Pharma Phils., Inc.

[Astellas Pharma Tech Co.,

Ltd. – Japan]

DR-XY34109

400 mcg

Prolonged-release

Tablet

HARNAL

OCAS

Astellas Pharma Phils., Inc.

[Astellas Pharma Europe

B.V. – Netherlands]

DR-XY33041

400 mcg Enteric-

coated Tablet

The comparator product for Tamsulosin in enteric-coated tablet is

not available locally. This should be purchased from a well

regulated market with stringent regulatory authority (SRA).

Tamsulosin

Hydrochloride +

Dutasteride

400mcg/500mcg

Capsule

DUODART GlaxoSmithKline

Philippines, Inc. [Catalent

Germany Schorndorf

GmbH – Germany]

DR-XY39352

Tapentadol (as

Hydrochloride)

50mg Tablet NUCYNTA IR Johnson & Johnson (Phils.)

Inc. [Janssen Ortho LLC –

Puerto Rico]

DR-XY45577

75mg Tablet NUCYNTA IR Johnson & Johnson (Phils.)

Inc. [Janssen Ortho LLC –

Puerto Rico]

DR-XY45576

100mg Tablet NUCYNTA IR Johnson & Johnson (Phils.)

Inc. [Janssen Ortho LLC –

Puerto Rico]

DR-XY45575

50mg Extended-

Release Tablet

NUCYNTA ER Johnson & Johnson (Phils.)

Inc. [Janssen Ortho LLC –

Puerto Rico]

DR-XY45795

100mg Extended-

Release Tablet

NUCYNTA ER Johnson & Johnson (Phils.)

Inc. [Janssen Ortho LLC –

Puerto Rico]

DR-XY45794

150mg Extended-

Release Tablet

NUCYNTA ER Johnson & Johnson (Phils.)

Inc. [Janssen Ortho LLC –

Puerto Rico]

DR-XY45578

200mg Extended-

Release Tablet

NUCYNTA ER Johnson & Johnson (Phils.)

Inc. [Janssen Ortho LLC –

Puerto Rico]

DR-XY45580

250mg Extended-

Release Tablet

NUCYNTA ER Johnson & Johnson (Phils.)

Inc. [Janssen Ortho LLC –

Puerto Rico]

DR-XY45579

Tedizolid Phosphate 200MG Tablet SIVEXTRO Bayer Philippines, Inc.

[Patheon Inc. – Canada]

DR-XY45815

Tegafur + Uracil 100mg/224mg

Capsule

UFT Merck, Inc. [Taiho

Pharmaceutical Co., Ltd. –

Japan]

DR-XY15894

Page 124:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

124

Telmisartan 20mg Tablet MICARDIS Boehringer Ingelheim

Limited2

Not available

locally

Boehringer Ingelheim3

40 mg Tablet MICARDIS Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY24851

PRITOR GlaxoSmithKline Phils.,

Inc. [Boehringer Ingelheim

Pharma GmbH & Co. KG

– Germany]

DR-XY25308

80 mg Tablet MICARDIS Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY24852

PRITOR GlaxoSmithKline Phils.,

Inc. [Boehringer Ingelheim

Pharma GmbH & Co. KG

– Germany]

DR-XY25307

Telmisartan +

Amlodipine besilate

40 mg/5 mg Tablet TWYNSTA Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY43360

40 mg/10 mg

Tablet

TWYNSTA Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY43363

80 mg/5 mg Tablet TWYNSTA Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY43362

80 mg/10 mg

Tablet

TWYNSTA Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY43361

Telmisartan +

Hydrochlorothiazide

40 mg/12.5 mg

Tablet

MICARDIS

PLUS

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY27204

PRITOR PLUS GlaxoSmithKline Phils.,

Inc. [Boehringer Ingelheim

Pharma GmbH & Co. KG

– Germany]

DR-XY27817

80 mg/12.5 mg

Tablet

MICARDIS

PLUS

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY27205

Page 125:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

125

PRITOR PLUS GlaxoSmithKline Phils.,

Inc. [Boehringer Ingelheim

Pharma GmbH & Co. KG

– Germany]

DR-XY27818

80 mg/25 mg

Tablet

MICARDIS

PLUS

Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY36121

PRITOR PLUS GlaxoSmithKline Phils.,

Inc. [Boehringer Ingelheim

Pharma GmbH & Co. KG

– Germany]

DR-XY37322

Temozolomide 5mg Capsule TEMODAL Merck Sharp & Dohme

Limited2

Not available

locally

TEMODAR Merck Sharp and Dohme

Corp.3

20mg Capsule TEMODAL Merck Sharp & Dohme

(I.A.) Corp. [Orion Corp. –

Finland]

DR-XY39522

100mg Capsule TEMODAL Merck Sharp & Dohme

(I.A.) Corp. [Orion Corp. –

Finland]

DR-XY39523

140mg Capsule TEMODAL Merck Sharp & Dohme

(I.A.) Corp. [Orion Corp. –

Finland]

DR-XY39524

180mg Capsule TEMODAL Merck Sharp & Dohme

Limited2

Not available

locally

TEMODAR Merck Sharp and Dohme

Corp.3

250mg Capsule TEMODAL Merck Sharp & Dohme

(I.A.) Corp. [Orion Corp. –

Finland]

DR-XY39525

Teneligliptin

hydrobromide

hydrate

20 mg Tablet TENELIA Mitsubishi Tanabe Pharma

Corp.4

Not available

locally

Tenofovir

Alafenamide (as

Fumarate)

25mg Tablet VEMLIDY Gilead Sciences Ltd.2 Not available

locally Gilead Sciences Inc.3

Tenofovir disoproxil

fumarate

150mg Tablet VIREAD Gilead Sciences Ltd.2 Not available

locally Gilead Sciences Inc.3

200mg Tablet VIREAD Gilead Sciences Ltd.2 Not available

locally Gilead Sciences Inc.3

250mg Tablet VIREAD Gilead Sciences Ltd.2 Not available

locally Gilead Sciences Inc.3

300 mg Film-

Coated Tablet

VIREAD LF (Philippines), Inc.

[Takeda GmbH –

Germany]

DR-XY43310

Page 126:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

126

40mg Oral

Granules/Powder

VIREAD Gilead Sciences Ltd.2 Not available

locally Gilead Sciences Inc.3

Tenoxicam 20mg Tablet MOBIFLEX Meda Pharmaceuticals2 Not available

locally

Terazosin (as

hydrochloride)

1 mg Tablet HYTRIN Abbott Labs. [Aesica

Queenborough Ltd. –

United Kingdom]

DRP-3676

2 mg Tablet HYTRIN Abbott Labs. [Aesica

Queenborough Ltd. –

United Kingdom]

DRP-3678

5 mg Tablet HYTRIN Abbott Labs. [Aesica

Queenborough Ltd. –

United Kingdom]

DRP-3677

10mg Tablet HYTRIN Concordia International –

formerly AMCo2

Not available

locally

Terbinafine (as

hydrochloride)

250 mg Tablet LAMISIL Novartis Healthcare

(Phils.), Inc. [Novartis

Pharma Productions GmbH

– Germany]

DR-XY15999

125mg Oral

Granule

LAMISIL Novartis Pharmaceuticals

Corp.3

Not available

locally

187.5mg Oral

Granule

LAMISIL Novartis Pharmaceuticals

Corp.3

Not available

locally

Terbutaline Sulfate 2.5mg Tablet BRICANYL AstraZeneca

Pharmaceutical

Philippines, Inc.

[AstraZeneca

Pharmaceutical Co. Ltd. –

China]

DR-XY39882

5mg Tablet BRICANYL AstraZeneca UK Limited Not available

locally

Testosterone

undecanoate

40 mg Capsule ANDRIOL

TESTOCAPS

Merck Sharp & Dohme

(I.A.) Corp. [Catalent

Australia Pty. Ltd. –

Australia]

DR-XY30237

Theophylline 125 mg Sustained-

Release Tablet

NUELIN SR 125 Metro Drug, Inc. [Adcock

Ingram Ltd. – India]

DR-XY41644

250 mg Sustained-

Release Tablet

NUELIN SR 250 Metro Drug, Inc. [Adcock

Ingram Ltd. – India]

DR-XY41645

Thalidomide 50mg Capsule THALIDOMID

E CELGENE

Celgene Ltd.2 Not available

locally

THALOMID Celgene Corp.3

100mg Capsule THALOMID Celgene Corp.3 Not available

locally

150mg Capsule THALOMID Celgene Corp.3 Not available

locally

Page 127:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

127

200mg Capsule THALOMID Celgene Corp.3 Not available

locally

Thiamazole

(Methimazole)

5 mg Tablet TAPAZOLE A. Menarini Phils., Inc.

[Interphil Labs., Inc.]

DRP-199

TAPAZOLE A. Menarini Phils., Inc.

[Interphil Labs., Inc.]

DR-4441

10 mg Tablet STRUMAZOL Aspen Phils., Inc. [Takeda

Christiaens – Belgium]

DR-XY38132

20 mg Tablet TAPAZOLE A. Menarini Phils., Inc.

[Interphil Labs., Inc.]

DRP-1691

30 mg Tablet STRUMAZOL Aspen Phils., Inc. [Takeda

Christiaens – Belgium]

DR-XY25715

Tibolone 2.5mg Tablet LIVIAL Merck Sharp & Dohme

(I.A.) Corporation [Merck

Sharp & Dohme B.V.

Legal Entitiy N.V.

Organon – Netherlands]

DR-XY22324

Ticagrelor 60mg Tablet BRILIQUE AstraZeneca UK Limited2 Not available

locally BRILINTA AstraZeneca

Pharmaceuticals LP3

90mg Tablet BRILINTA AstraZeneca

Pharmaceuticals (Phils.)

Inc. [AstraZeneca AB –

Sweden]

DR-XY40759

Tofacitinib (as

Citrate)

5mg Tablet XELJANZ Pfizer Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DR-XY43307

11mg Extended-

Release Tablet

XELJANZ XR Pfizer Inc.3 Not available

locally

Tolterodine Tartrate 1mg Tablet DETRUSITOL Pfizer Limited2 Not available

locally DETROL Pharmacia and Upjohn

Co.3

2mg Tablet DETRUSITOL Pfizer Limited2 Not available

locally DETROL Pharmacia and Upjohn

Co.3

2mg Prolonged-

/Extended-Release

Capsule

DETRUSITOL

XL

Pfizer Limited2 Not available

locally

DETROL LA Pharmacia and Upjohn

Co.3

4mg Prolonged-

/Extended-Release

Capsule

DETRUSITOL

XL

Pfizer Limited2 Not available

locally

SANTIZOR XL

DETROL LA Pharmacia and Upjohn

Co.3

Page 128:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

128

Topiramate 25 mg Tablet TOPAMAX Johnson & Johnson

(Phils.), Inc. [Cilag AG –

Switzerland]

DR-XY24422

50 mg Tablet TOPAMAX Johnson & Johnson

(Phils.), Inc. [Cilag AG –

Switzerland]

DR-XY24425

100 mg Tablet TOPAMAX Johnson & Johnson

(Phils.), Inc. [Cilag AG –

Switzerland]

DR-XY24424

200 mg Tablet TOPAMAX Janssen-Cilag2 Not available

locally Janssen Pharm’ls, Inc.3

15 mg Capsule TOPAMAX Janssen-Cilag2 Not available

locally Janssen Pharm’ls, Inc.3

25 mg Capsule TOPAMAX Janssen-Cilag2 Not available

locally Janssen Pharm’ls, Inc.3

50 mg Capsule TOPAMAX Janssen-Cilag2 Not available

locally

Topotecan (as

Hydrochloride)

250mcg Capsule HYCAMTIN GlaxoSmithKline Phils.

Inc. [GlaxoSmithKline

Manufacturing S.p.A. –

Italy]

DR-XY36258

1mg Capsule HYCAMTIN GlaxoSmithKline Phils.

Inc. [GlaxoSmithKline

Manufacturing S.p.A. –

Italy]

DR-XY36258

Tramadol

hydrochloride

50 mg Capsule TRAMAL Mundipharma Distribution

GmbH (Phil. Branch)

[Farmaceutici Formenti

S.p.A. – Italy]

DR-XY4359

100mg Prolonged-

/Extended-Release

Capsule

TRAMAL OAD Mundipharma Distribution

GmbH (Phil. Branch)

[SMB Technology S.A. –

Germany]

DR-XY39527

150mg Prolonged-

/Extended-Release

Capsule

TRAMAL OAD Mundipharma Distribution

GmbH (Phil. Branch)

[SMB Technology S.A. –

Germany]

DR-XY39528

200mg Prolonged-

/Extended-Release

Capsule

TRAMAL OAD Mundipharma Distribution

GmbH (Phil. Branch)

[SMB Technology S.A. –

Germany]

DR-XY39529

300mg Prolonged-

/Extended-Release

Capsule

CONZIP Cipher Pharmaceuticals

Inc.3

Not available

locally

50mg Tablet ULTRAM Janssen Pharmaceuticals

Inc3

Not available

locally

Page 129:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

129

50 mg Dispersible

Tablet

TRAMAL Mundipharma Distribution

GmbH (Phil. Branch)

[Farmaceutici Formenti

S.p.A. – Italy]

DR-XY27451

50 mg Prolonged-

Release Tablet

TRAMAL

RETARD

Mundipharma Distribution

GmbH (Phil. Branch)

[Farmaceutici Formenti

S.p.A. – Italy]

DR-XY38206

100 mg Prolonged-

Release Tablet

TRAMAL

RETARD

Mundipharma Distribution

GmbH (Phil. Branch)

[Farmaceutici Formenti

S.p.A. – Italy]

DR-XY22623

TRAMUNDIN

RETARD

Mundipharma Distribution

GmbH (Phil. Branch)

[Mundipharma GmbH –

Germany]

DR-XY25474

150 mg Prolonged-

Release Tablet

TRAMUNDIN

RETARD

Mundipharma Distribution

GmbH (Phil. Branch)

[Mundipharma GmbH –

Germany]

DR-XY25472

TRAMAL

RETARD

Mundipharma Distribution

GmbH (Phil. Branch)

[Farmaceutici Formenti

S.p.A. – Italy]

DR-XY38208

200 mg Prolonged-

Release Tablet

TRAMUNDIN

RETARD

Mundipharma Distribution

GmbH (Phil. Branch)

[Mundipharma GmbH –

Germany]

DR-XY25473

TRAMAL

RETARD

Mundipharma Distribution

GmbH (Phil. Branch)

[Farmaceutici Formenti

S.p.A. – Italy]

DR-XY38207

300mg Prolonged-

Release Tablet

ZYDOL XL Grunenthal Ltd.2 Not available

locally

400mg Prolonged-

Release Tablet

ZYDOL XL Grunenthal Ltd.2 Not available

locally

Tramadol

hydrochloride +

Paracetamol

37.5 mg/325 mg

Tablet

DOLCET Johnson & Johnson

(Phils.), Inc. [Janssen

Korea Ltd. – Korea]

DR-XY28928

DOLCET Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

S.p.A. – Italy]

DR-XY35024

Trandolapril 1mg Tablet MAVIK Abbvie Inc.3 Not available

locally

2mg Tablet MAVIK Abbvie Inc.3 Not available

locally

Page 130:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

130

4mg Tablet MAVIK Abbvie Inc.3 Not available

locally

Tranexamic Acid 250 mg Capsule HEMOSTAN Biomedis, Inc. [Amherst

Labs., Inc.]

DR-5167

500 mg Capsule HEMOSTAN Biomedis, Inc. [Amherst

Labs., Inc.]

DRP-2847

500mg Tablet CYKLOPARON Meda Pharmaceuticals2 Not available

locally

650mg Tablet LYSTEDA Ferring Pharmaceuticals

AS3

Not available

locally

Triflusal 300mg Capsule GRENDIS Abbott Products

(Philippines), Inc. [J.

Uriach & Cia. S.A. –

Spain]

DR-XY30166

Trimetazidine

hydrochloride

20 mg Tablet VASTAREL 20 Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY2643

35 mg Modified-

Release Tablet

VASTAREL

MR

Servier Phils., Inc. [Les

Laboratoires Servier

Industrie – France]

DR-XY27357

VASTAREL

MR

Servier Phils., Inc. [Kotra

Pharma (M) Sdn. Bhd. –

Malaysia]

DR-XY42588

Trimipramine (as

Maleate)

25mg Tablet SURMONTIL Patriot Pharmaceuticals

Corp. [Famar Lyon –

France]

DR-X8493

25mg Capsule SURMONTIL Odyssey Pharmaceuticals

Inc.3

Not available

locally

50mg Capsule SURMONTIL Odyssey Pharmaceuticals

Inc.3

Not available

locally

75mg Capsule SURMONTIL Odyssey Pharmaceuticals

Inc.3

Not available

locally

Tropisetron

hydrochloride

5 mg Capsule NAVOBAN Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY17560

Ulipristal Acetate 5mg Tablet ESMYA OEP Philippines, Inc.

[Cenexi – France]

DR-XY44905

30mg Tablet ELLAONE HRA Pharma UK and

Ireland Limited2

Not available

locally

ELLA Laboratoire HRA Pharma3

Ursodeoxycholic

Acid

150 mg Tablet DESTOLIT Norgine Limited – United

Kingdom2

Not available

locally

250mg Tablet URSO 250 Forest Laboratories Inc.3 Not available

locally

500 mg Tablet URSOFALK A. Menarini Phils., Inc.

[Losan Pharma GmbH –

Germany]

DR-XY43043

Page 131:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

131

250 mg Capsule URSOFALK A. Menarini Phils., Inc.

[Dr. Falk Pharma GmbH –

Germany]

DR-X8308

300 mg Capsule ACTIGALL Actavis Laboratories UT,

Inc. – USA3

Not available

locally

250mg/5mL Oral

Suspension

URSOFALK Dr. Falk Pharma UK Ltd.2 Not available

locally

Valaciclovir (as

Hydrochloride)

250mg Tablet VALTREX GlaxoSmithKline UK2 Not available

locally

500mg Tablet VALTREX GlaxoSmithKline Phils.

Inc. [Glaxo Wellcome S.A.

– Spain]

DR-XY20263

1g Tablet VALTREX GlaxoSmithKline3 Not available

locally

Valganciclovir (as

Hydrochloride)

450mg Tablet VALCYTE Roche Philippines Inc.

[Patheon Inc. – Canada]

DR-XY28808

Valsartan 40 mg Tablet DIOVAN Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DR-XY33957

80 mg Tablet DIOVAN Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DRP-5124

160 mg Tablet DIOVAN Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DRP-5123

320 mg Tablet DIOVAN Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DRP-5122

Valsartan +

Hydrochlorothiazide

80mg/12.5mg

Tablet

CO-DIOVAN Novartis Healthcare Phils.

Inc. [Novartis Farma

S.p.A. – Italy]

DRP-371

160mg/12.5mg

Tablet

CO-DIOVAN Novartis Healthcare Phils.

Inc. [Novartis Farma

S.p.A. – Italy]

DR-XY27070

160mg/25mg

Tablet

CO-DIOVAN Novartis Healthcare Phils.

Inc. [Novartis Farma

S.p.A. – Italy]

DRP-372

320mg/12.5mg

Tablet

CO-DIOVAN Novartis Healthcare Phils.

Inc. [Novartis Farma

S.p.A. – Italy]

DR-XY34349

320mg/25mg

Tablet

CO-DIOVAN Novartis Healthcare Phils.

Inc. [Novartis Farma

S.p.A. – Italy]

DR-XY34350

Vardenafil (as

Hydrochloride)

2.5mg Tablet LEVITRA Bayer Healthcare

Pharmaceuticals Inc.3

Not available

locally

Page 132:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

132

5mg Tablet LEVITRA Bayer Philippines, Inc. [

Bayer Pharma AG –

Germany]

DR-XY28559

10mg Tablet LEVITRA Bayer Philippines, Inc. [

Bayer Pharma AG –

Germany]

DR-XY28558

20mg Tablet LEVITRA Bayer Philippines, Inc. [

Bayer Pharma AG –

Germany]

DR-XY28557

10mg Orally

Disintegrating

Tablet

LEVITRA Bayer plc2 Not available

locally STAXYN Bayer Healthcare

Pharmaceuticals Inc.3

Varenicline (as

Tartrate)

500mcg Tablet CHAMPIX Pfizer Inc. [Pfizer

Manufacturing

Deustchland GmbH –

Germany]

DR-XY33475

1mg Tablet CHAMPIX Pfizer Inc. [Pfizer

Manufacturing

Deustchland GmbH –

Germany]

DR-XY33473

Vemurafenib 240mg Tablet ZELBORAF Roche (Philippines), Inc.

[Roche S.p.A. – Italy]

DR-XY41974

Venlafaxine (as

Hydrochloride)

37.5mg Prolonged-

/Extended-Release

Capsule

EFFEXOR XR Wyeth Pharmaceuticals

Inc.3

Not available

locally

75mg Prolonged-

/Extended-Release

Capsule

EFEXOR XL Pfizer Limited2 Not available

locally EFFEXOR XR Wyeth Pharmaceuticals

Inc.3

150mg Prolonged-

/Extended-Release

Capsule

EFEXOR XL Pfizer Limited2 Not available

locally EFFEXOR XR Wyeth Pharmaceuticals

Inc.3

225mg Prolonged-

/Extended-Release

Capsule

EFEXOR XL Pfizer Limited2 Not available

locally

Verapamil

hydrochloride

40 mg Tablet ISOPTIN Abbott Labs. [Abbott

GmbH & Co. KG –

Germany]

DR-XY23051

80 mg Tablet ISOPTIN Abbott Labs. [Abbott

GmbH & Co. KG –

Germany]

DR-XY23052

120mg Tablet CALAN GD Searle LLC3 Not available

locally

120mg Extended-

Release Tablet

CALAN SR GD Searle LLC3 Not available

locally

180 mg Sustained-

release Tablet

ISOPTIN SR Abbott Labs. [Abbott

GmbH & Co. KG –

Germany]

DR-XY20086

(in bottle)

Page 133:  · Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City,

133

ISOPTIN SR Abbott Labs. [Abbott

GmbH & Co. KG –

Germany]

DR-XY42927

(in blister pack)

240 mg Sustained-

release Tablet

ISOPTIN SR Abbott Labs. [Abbott

GmbH & Co. KG –

Germany]

DR-XY5075

(in bottle)

ISOPTIN SR Abbott Labs. [Abbott

GmbH & Co. KG –

Germany]

DR-XY40832

(in blister pack)

100mg Extended-

Release Capsule

VERELAN PM Recro Gainesville LLC3 Not available

locally

120mg Extended-

Release Capsule

VERELAN PM Recro Gainesville LLC3 Not available

locally

180mg Extended-

Release Capsule

VERELAN PM Recro Gainesville LLC3 Not available

locally

200mg Extended-

Release Capsule

VERELAN PM Recro Gainesville LLC3 Not available

locally

240mg Extended-

Release Capsule

VERELAN PM Recro Gainesville LLC3 Not available

locally

300mg Extended-

Release Capsule

VERELAN PM Recro Gainesville LLC3 Not available

locally

360mg Extended-

Release Capsule

VERELAN PM Recro Gainesville LLC3 Not available

locally

Verapamil

Hydrochloride +

Trandolapril

180mg/2mg

Sustained-

/Extended-Release

Tablet

TARKA Abbott Laboratories

[AbbVie Deutschland

GmbH & Co. KG –

Germany]

DR-XY31782

240mg/1mg

Sustained-

/Extended-Release

Tablet

TARKA Abbvie Inc.3 Not available

locally

240mg/2mg

Sustained-

/Extended-Release

Tablet

TARKA Abbvie Inc.3 Not available

locally

240mg/4mg

Sustained-

/Extended-Release

Tablet

TARKA Abbvie Inc.3 Not available

locally

Vildagliptin 50 mg Tablet GALVUS Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Stein AG – Switzerland]

DRP-4796

Vildagliptin +

Metformin

hydrochloride

50 mg/500 mg

Tablet

GALVUSMET Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Produktions GmbH –

Germany]

DRP-4893

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134

50 mg/850 mg

Tablet

GALVUSMET Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Produktions GmbH –

Germany]

DRP-4795

50 mg/1 g Tablet GALVUSMET Novartis Healthcare Phils.,

Inc. [Novartis Pharma

Produktions GmbH –

Germany]

DRP-4797

Vinorelbine (as

Tartrate)

20mg Capsule NAVELBINE OEP Philippines Inc.

[Pierre Fabre Medicament

Production – France]

DR-XY44861

30mg Capsule NAVELBINE OEP Philippines Inc.

[Pierre Fabre Medicament

Production – France]

DR-XY44860

80mg Capsule NAVELBINE Pierre Fabre Limited2 Not available

locally

Vismodegib 150mg Capsule ERIVEDGE Roche (Philippines), Inc.

[Patheon Inc. – Canada]

DR-XY43318

Voglibose 200 mcg Tablet BASEN Takeda Healthcare Phils.,

Inc. (Takeda Pharma’l Co.,

Ltd. – Japan]

DR-XY22512

300 mcg Tablet BASEN Takeda Healthcare Phils.,

Inc. (Takeda Pharma’l Co.,

Ltd. – Japan]

DR-XY22513

Voriconazole 50mg Tablet VFEND Pfizer Limited2 Not available

locally PF Prism CV3

200mg Tablet VFEND Pfizer Inc. [Pfizer Italia

S.r.l. – Italy]

DR-XY32882

40mg/mL

(200mg/5mL)

Powder for Oral

Suspension

VFEND Pfizer Limited2 Not available

locally PF Prism CV3

Vortioxetine (as

Hydrobromide)

5mg Tablet BRINTELLIX Metro Drug Inc. [H.

Lundbeck A/S – Denmark]

DR-XY44630

10mg Tablet BRINTELLIX Metro Drug Inc. [H.

Lundbeck A/S – Denmark]

DR-XY44629

15mg Tablet BRINTELLIX Metro Drug Inc. [H.

Lundbeck A/S – Denmark]

DR-XY44632

20mg Tablet BRINTELLIX Metro Drug Inc. [H.

Lundbeck A/S – Denmark]

DR-XY44631

Warfarin sodium 1 mg Tablet COUMADIN A. Menarini Phils., Inc.

[Taro Pharm’l Industries

Ltd. – Israel]

DR-XY14880

2mg Tablet COUMADIN Bristol Myers Squibb

Pharma Co.3

Not available

locally

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135

2.5 mg Tablet COUMADIN A. Menarini Phils., Inc.

[Taro Pharm’l Industries

Ltd. – Israel]

DR-3744

3mg Tablet COUMADIN Bristol Myers Squibb

Pharma Co.3

Not available

locally

4mg Tablet COUMADIN Bristol Myers Squibb

Pharma Co.3

Not available

locally

5 mg Tablet COUMADIN A. Menarini Phils., Inc.

[Taro Pharm’l Industries

Ltd. – Israel]

DR-3745

6mg Tablet COUMADIN Bristol Myers Squibb

Pharma Co.3

Not available

locally

7.5mg Tablet COUMADIN Bristol Myers Squibb

Pharma Co.3

Not available

locally

10mg Tablet COUMADIN Bristol Myers Squibb

Pharma Co.3

Not available

locally

Zolmitriptan 2.5mg Tablet ZOMIG AstraZeneca

Pharmaceuticals (Phils.)

Inc. [IPR Pharmaceutical

Inc. – Puerto Rico]

DR-XY26129

5mg Tablet ZOMIG IPR Pharmaceuticals Inc.3 Not available

locally

2.5mg Orally

Disintegrating

Tablet

ZOMIG

RAPIMELT

AstraZeneca UK Limited2 Not available

locally

ZOMIG-ZMT AstraZeneca

Pharmaceuticals LP3

5mg Orally

Disintegrating

Tablet

ZOMIG

RAPIMELT

AstraZeneca UK Limited2 Not available

locally

ZOMIG-ZMT AstraZeneca

Pharmaceuticals LP3

Zolpidem (as

Tartrate)

5mg Tablet STILNOCT Sanofi2 Not available

locally AMBIEN Sanofi Aventis US LLC3

10mg Tablet STILNOX Sanofi-Aventis Philippines

Inc. [Sanofi Winthrop

Industries – France]

DRP-014

6.25mg Extended-

Release Tablet

AMBIEN CR Sanofi Aventis US LLC3 Not available

locally

12.5 Extended-

Release Tablet

AMBIEN CR Sanofi Aventis US LLC3 Not available

locally

1.75mg Sublingual

Tablet

INTERMEZZO Purdue Pharma Products

LP3

Not available

locally

3.5mg Sublingual

Tablet

INTERMEZZO Purdue Pharma Products

LP3

Not available

locally

5mg Sublingual

Tablet

EDLUAR Mylan Specialty LP3 Not available

locally

10mg Sublingual

Tablet

EDLUAR Mylan Specialty LP3 Not available

locally

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136

Zonisamide 25mg Tablet ZONEGRAN Hi-Eisai Pharmaceutical

Inc. [Dainipin Sumitomo

Pharma Co. Ltd. – Japan]

DR-XY33776

Hi-Eisai Pharmaceutical

Inc. [Bora Pharmaceutical

Co. Ltd. – Taiwan]

DR-XY43996

25mg Capsule ZONEGRAN Eisai Ltd.2 Not available

locally Sunovion Pharmaceuticals

Inc.3

50mg Capsule ZONEGRAN Eisai Ltd.2 Not available

locally Sunovion Pharmaceuticals

Inc.3

100mg Capsule ZONEGRAN Eisai Ltd.2 Not available

locally Sunovion Pharmaceuticals

Inc.3

1In case the comparator drug product is not available in the Philippines, the global innovator (or in its absence, an alternative

comparator) should be purchased from a well regulated market with stringent regulatory authority (SRA). Documentary

proof of purchase, shipping and storage of the comparator product from the site of purchase to the BE testing center should

be provided.

An SRA is a regulatory authority, which is:

a. a member of the International Council for Harmonization of Technical Requirements for Registration of

Pharmaceuticals for Human Use (ICH) prior to 23 October 2015, namely: the US Food and Drug Administration

(FDA), the European Commission (EC) and the Ministry of Health, Labor and Welfare (MHLW) of Japan also

represented by the Pharmaceuticals and Medical Devices Agency (PMDA); or

b. an ICH Observer prior to 23 October 2015, namely: the European Free Trade Association (EFTA) as represented

by SwissMedic and Health Canada; or

c. a regulatory authority associated with an ICH member through a legally binding mutual recognition agreement

prior to 23 October 2015, namely: Australia, Iceland, Liechtenstein and Norway.

2The comparator product should be purchased from the market within the European Union (EU). 3The comparator product should be purchased from the US market. 4The comparator product should be purchased from the market of Japan.